a systematic review of the effects of acupuncture

CLINICAL REVIEW

A systematic review of the

Wei Huang a,*, Nancy

a VA Medical Center at AtlantEmory University School of Meb Department of Rehabilitatioc Department of Neurology, Em

studies and mixed results from those with sham (or unreal treatment) controls.

insomnia, with proper sham and blinding procedures will be required in the future.This review highlights aspects of acupuncture treatments important to guide future

stance for sleep.1 It affects more than 60 millionAmericans each year. Approximately 1/3 of

Huang), [email protected] (N. Kutner), [email protected](D.L. Bliwise).

1087-0792/$ -doi:10.1016/j.

Sleep Medicine Reviews (2009) 13, 73e104Introduction

Insomnia is defined as sleep onset, sleep mainte-nance, and early awakening problems in thepresence of adequate opportunity and circum-

* Corresponding author.E-mail addresses: [email protected] (W.research and clinical practice.Published by Elsevier Ltd.Of the thirty studies, twelve were clinical trials with only three double-blinded.Only five used sham controls, and of these, four showed statistically significantdifferences favoring real treatments; however, none evaluated the adequacy ofsham assignment. Three studies used actigraphy or polysomnography as objectiveoutcome measures. The considerable heterogeneity of acupuncture techniquesand acupoint selections among all studies made the results difficult to compareand integrate. High-quality randomized clinical trials of acupuncture in treatingKEYWORDSAcupuncture;Insomnia;Sleep;Traditional ChineseMedicinesee front matter Publissmrv.2008.04.002Kutner b, Donald L. Bliwise c

a, Department of Physical Medicine and Rehabilitation,dicine, 1670 Clairmont Road, Decatur, GA 30033, USAn Medicine, Emory University School of Medicine, Atlanta, GA 30322, USAory University School of Medicine, Atlanta, GA 30322, USA

Summary To examine the extent to which research supports the use of acupunc-ture in treating insomnia, a systematic review was conducted that included not onlyclinical trials, but also case series in both English and Chinese literature. Thirtystudies were included in the review, 93% of which showed positive treatmenteffects of acupuncture in improving various aspects of sleep. Although acupuncturehas been demonstrated to be safe and holds great potential to be an effectivetreatment modality for insomnia, the evidence is limited by the quality of thesein treating insomniahed by Elsevier Ltd.effects of acupuncture

www.elsevier.com/locate/smrv

general population2 and half of managed care In TCM, poor sleep can also be associated with

guide the flow of bio-energy in human bodies.

74 W. Huang et al.patients report insomnia.3 Many risk factors havebeen identified for insomnia including femalegender, older age, comorbid chronic medicalconditions and psychiatric disorders, variousmedications, and life style factors, e.g., caffeineintake, smoking, and reduced physical activity.1

Due to limitations and concerns with currentavailable insomnia treatments, a sizable propor-tion of the population, especially in Europe andChina, has turned to complementary alternativemedicine, including acupuncture, in searching fora treatment modality with potential efficacy andfew side effects.4 In the US, acupuncture has seenvery limited use in sleep and there have beenlimited literature reviews to examine this modal-ity.5e7 The most recent review of acupuncture insleep5 attempted a meta-analysis and failed todemonstrate significant efficacy of acupuncturecompared with various control treatments. Thatreview was limited because the studies includedwere selected from English literature only anddifferent acupuncture techniques, control groups,and outcome measures were not reviewedsystematically.

Acupuncture is a clinical treatment modality inan independent medical system of TraditionalChinese Medicine (TCM),8 which was developedover 3000 years ago under the influence of orientalphilosophical theories, such as Yin-Yang, FiveElements and Dialectical Unity. It has progressedthrough many years of clinical observations andpractice. In TCM, there is no concept of isolatedorgan function but rather a focus on interactionsamong different organ systems. TCM diagnosesconnote syndromes in Western medicine, witha combination of symptoms. For instance, heartis not just the 4-chambered blood-pump. It notonly controls vascular circulation but also isdefined as the center of life as well as mind, withits external manifestations on tongue and face.Although these connections are not intuitive inWestern medicine, they arise from long-termclinical observations. For example, TCM teachesthat people with cardiac conditions often haveabnormal facial complexion and tongue color,anxiety, sleep problems and cognitive dysfunc-tion.9 Heart deficiency is one of the TCMdiagnoses for insomnia (Table 1). Interestingly,in Western medicine, such associations also playa role in physical diagnosis. For instance, blue lipsand fingers in children may indicate cyanosis asa part of congenital heart disease. In addition,Western medicine increasingly acknowledges therelationship of insomnia to both cardiovasculardiseases and psychological disturbances.10,11Through many years of practice, with variousinterpretations and innovations worldwide,acupuncture has evolved into numerous treatmenttechniques with acupoint selections varying frompractitioner to practitioner13 (see Table 2 for thosetechniques included in this review).

Given the challenge of this complex diagnosticand therapeutic system for treating insomniausing acupuncture, a more complete andsystematic review of available literature isnecessary to further guide future clinical andresearch directions. By widening our perspectiveon the range of study designs and types of broadlydefined acupuncture techniques, we hope, in thisreview, to highlight critical areas that should beaddressed in future clinical trials and studies ofunderlying mechanisms.

Materials and methods

Search methods for identification of studies

Computerized databases, including MEDLINE(1950e2007), All Evidence-Based Medicine (EBM)ReviewsdCochrane Database of SystematicReviews (DSR), American College of Physicians(ACP) Journal Club, Database of Abstracts ofReviews of Effects (DARE), and CochraneControlled Trials Register (CCTR) (through July2007), PsycINFO (1806e2007), CINAHLdCumula-tive Index to Nursing & Allied Health Literature(1982e2007) were searched under key wordsacupuncture, and insomnia or sleep. Inaddition, relevant references in the reviewedarticles were also included, if obtainable viaother organ system dysfunction. By performinga complete review of all symptoms, in combinationwith physical examination, particularly pulse andtongue examinations, one arrives at a TCM diag-nosis for insomnia (Table 1).9,12 The TCM diag-noses can also change from time to time due toprogression or resolution of various symptoms.Therefore, TCM treatments, including acupunc-ture, are targeted towards regulating andbalancing the functions of different organ systems.In clinical practice, patients with the same sleepproblem can get different acupuncture treat-ments, depending on individual differences in bothpresumed etiology and dynamic changes of symp-toms over time.

Basic acupuncture technique is to insertacupuncture needles into selected acupoints alongmeridians, which are the channels believed to

Table 1 Traditional Chinese Medicine insomnia diagnoses and acupuncture treatment rules

TCM diagnoses Common clinical symptoms and signs Common sleepproblems

Possible disease condition Acupuncture treatment rules

Heart and spleen deficiency Palpitation, easy fatigue, vertigo/dizziness, sweaty,no taste in mouth, anorexia, amnesia, females withmenstruation abnormalities; pale complexion, paletongue proper with thin-whitish covering, fine andweak pulse

Insomnia with difficultyremaining asleep: frequentdreams and awakenings,hard to go back to sleeponce awake

Acute (from extremeworries and fatigue),chronic

To nourish heart and tostrengthen spleen

Incoordination between theheart and the kidney; orkidney Yin deficiency; orYin deficiency leading toexcessive fire

Vexation, vertigo/dizziness, tinnitus, palpitation,amnesia, low back ache, nocturia, feverishsensation in the chest, palms and soles, dry mouth,sore throat, impotence if severe; abscesses overthe mouth and tongue, red tongue proper,thready pulse

Insomnia ofall kinds

Chronic, usuallyfrom long-termmedicalconditions

To nourish Yin and drain fire

Heart and gallbladder Qia

deficiencyPalpitation, alertness, fearful, shortness of breath,lassitude; pale tongue proper,thin-whitish covering, taut-fine pulse

Insomnia with frequentdreams and mid-sleepstartling awakenings

Acute, chronic To nourish Qi, calm downspirits and mind

Disturbance of liver yang; orexcessive liver fire due toemotional suppression

Anxiety/depression, angry (internal or external),irritable, dry mouth or having bitter taste in mouth,dizziness/headaches, bloating feeling or pain in thechest, constipation; red eyes, dark yellow urine, redtongue proper, yellowish covering, taut-rapid pulse

Insomnia with onset difficulty,if asleep,wakes up early

Acute, chronic To drain liver fire, calm downmind

Liver and kidneyYin deficiency

Dizziness, headaches, anxiety and irritability, backand leg soreness and weakness, yellowish urine;tongue proper red with thin yellow coating, deepand fine pulse

Insomnia with frequentdreams

Chronic To nourish kidney and liverYin, drain fire if present

Disturbance of heart dueto phlegm heat

Always feeling bad, worrisome, c/o vertigo/dizziness,fullness in the head/chest, bitter taste in mouth,sputum production, aversion to food, acidregurgitation, hypochondria; reddish tongue proper(tip), yellow and greasy coating, slippery and rapidpulse

Insomnia Chronic To drain heat, dissolvesputum, regulate stomachfunction, and calm the mind

Unsynchronized spleenand stomach

Fullness in the stomach, anxious and cannotcalm down, hiccups/belching, regurgitation.If chronic: bad breaths, thick and greasytongue coating, slippery pulse

Sleep onset difficulty Acutedusually foodstagnation; ifchronicdusually long-term GI conditions

To stimulate stomachmotility, assist in digestion

All abbreviations, except for those representing different study groups as indicated in the table, are listed in the Appendices.a Qi: a concept in Traditional Chinese Medicine that refers to the vital energy that sustains life activities and physiological functions of viscera and organs.

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Table 2 Introduction of acupuncture techniques mentioned in the included studies

Acupuncturetechniques

Description

Regular bodyacupuncture

Fine gauge acupuncture needles, usually of gauge 28e38*, penetrate the skin at selected acupoints out of 14 main meridians and extra-meridian pointsto achieve desired treatment effects. Different schools of acupuncture practice use different manipulations, such as manual thrusting and twirling,electrical stimulation, or simply leaving the needles in for certain amount of time. In TCM, the depth of the needles depends on the chosen acupoint,goal of treatment, age of the patients, and other variables.*A regular injection needle is of gauge 22e25; the larger the number, the smaller the needle size.

Special body acupunctureIntradermal needle This technique leaves acupuncture needles embedded in the acupoints for prolonged period of time, from 24 h to a week.Plum blossom needle A piece of equipment made of 5e7 needles at one end (plum blossom shaped) and a handle at the other end is used to tap usually a large skin area,

such as back, shoulder, or gluteal region. The stimulation intensity depends on the tapping intensity. The goal result ranges from skin redness to slightbleeding.

Rolling needle A new type of multiple-needle equipment with dull needle-shaped spikes attached to a round shaft, which can be rolled to stimulate an entiremeridian, for instance back gall-bladder meridian. The goal is to produce skin redness.

Hydro-needle Instead of dry needle, hydro-needle technique injects various medications, such as herbal medications or local anesthetics into acupoints.Herbal acupointtaping

Use herb soaked tapes to cover acupoint(s). The idea is to have the herb penetrating into the body and produce treatment effects. Because skin isimpermeable to outside material, this technique is only commonly used at umbilical region.

Dual-acupointsneedling

Use one needle to penetrate two acupoints at the same time.

Auricular acupuncture Auricular acupoints, initially described in TCM and later advanced into a microsystem by a French physician, Paul Nogier, can be used to treat diseaseswith various techniques. The ones used in the reviewed studies include needling, semen vaccariae seeds taping and pressing to produce pressure,magnetic pearls taping to give presumed continuous magnetic field stimulation, lidocaine injection, laser irradiation, blood letting, all of which aredesigned to induce or block stimulation at the auricular acupoints.

Scalp acupuncture Although there are many scalp points along some traditional acupuncture meridians, scalp acupuncture is a specific terminology used internationally todescribe a specific acupuncture treatment system, developed initially by Chinese acupuncturists and later systematized by a Japanese physician,Toshikatsu Yamamoto. This system is similar to the auricular system where zones of the body are reflected on the scalp regions. Needles are usuallyinserted within a thin layer of loose tissue beneath the scalp surface at a low angle, many times with electro-stimulation. The most used applicationsare neurological conditions.

Moxibustion Moxa is made of dry and grounded mugwort herb, which is believed to increase blood circulation. Moxibustion is the burning of moxa directly orindirectly at acupoints. Direct application can cause scarring, which was used originally but is now less acceptable. Indirect application is morecommonly used to transmit heat from moxibustion to the acupoints via various ways. In TCM, this technique is commonly used to purge cold and warmup meridian for the treatment of certain conditions.

Sham acupuncture A technique that is only used in acupuncture research to mimic similar psychological experience for the subjects that could happened when theyinteract with the interventionist, assuming the acupuncture is done to them. Various ways of achieving this have been adopted throughout theacupuncture research history, such as applying pressure or needling at different points than real acupoints, using the same acupoints but withoutneedle penetration, using fake needles, and etc. The details of sham acupuncture that were used in the studies included in this review 15,19,20,22,24 arelisted with each of those individual studies in Table 3.

All abbreviations, except for those representing different study groups as indicated in the table, are listed in the Appendices.

76W.Huangetal.

interlibrary loan within the US. Due to the limita-

tary alternative medicine.

6. Study groups and number of subjects in each

The quality of the studies was assessed in the

Acupuncture for insomnia 772. Treatments focused on other sleep disorderssuch as sleep apnea, night terrors, orsomnambulism.

3. Multiple publications reporting the same groupof participants or their subsets.

After applying these criteria, 30 articles ofinsomnia treated with acupuncture were selectedand reviewed in detail in the followingcategories:

1. Clinical trials with or without blinding (n12).2. Case series (n18).

Methods of review

We attempted to extract the following data whenpossible:

1. Author, year of publication2. Country3. Study design:

a. Clinical trials: group assignment method,control groups, blinding (single, double) andblinding process assessment, risk of bias.

b. Case series: control of confounders, expo-sure bias, attrition bias, measurement bias,risk of bias.

4. Population studied: age, gender, referralsources, sleep difficulty description orinsomnia diagnosis criteria, duration of thecondition

5. Total number of subjectstion on Chinese databases access, we were unableto retrieve the entire body of Chinese literature onacupuncture and insomnia and only includedstudies published in peer-reviewed journals thatare searchable through the above-mentioneddatabases. A total of 332 articles were screenedinitially according to the following selectioncriteria:

Inclusion criteria:

1. Articles written in English or Chineselanguages.

2. Human studies.3. Original case series or clinical trials published

in peer-reviewed journals.

Exclusion criteria:

1. Although acupuncture was mentioned, themain treatment modality was complemen-Clinical trials of acupuncture in treatinginsomnia (details see Table 3)

1. Included studies: 12.15e26

2. Group assignmentmethod: 8/1216,18,20e24,26 notreported; for the remaining 4 studies,15,17,19,25

reported methods vary significantly fromparticipation date convenience to computer-ized randomization.following areas according to the Cochrane Hand-book for Systemic Reviews of Interventions14:

1. Selection bias: systematic differences incomparison groups (adequacy of randomiza-tion process or control of confounders).

2. Performance bias: systematic differences incare provided apart from the interventionbeing evaluated (treatment blinding process ormeasurement of exposure).

3. Attrition bias: systematic differences in with-drawals/dropouts from the trial or complete-ness of follow-up.

4. Detection bias: systematic differences inoutcome assessment (outcome measureblinding process or the bias of measurements).

The overall quality of the studies is summarizedinto the following three categories after assessingthe above four areas:

A. Low risk of bias: all the validity criteria weremet.

B. Moderate risk of bias: at least one validitycriterion was only partly met.

C. High risk of bias: at least one validity criterionwas completely not met.

Resultsgroup7. Detailed regimen for intervention or control8. Acupoints used, including acupuncture

techniques9. Outcome measurements10. Evaluation time points11. Results12. Notes: dropouts description, missing data and

other relevant notes

Quality assessment

able 3 Clinical trials of acupuncture in treating insomnia

uthoryear,rea)

Study design Population N Study groups Treatment Acupoints Eval F/U Results Notes

hen (1999,Taiwan)15

RCT: Groupassignmentmethod:Randomizedblock; Control:a. shamacupressure,b. conversation;Blinding:single blindingof real andsham groups(subjects);Risk of bias:category B.

Age: 61e98 yr;Gender:F:M32:52;Referral:a public assisted-living facility;Sleep difficulty:insomnia withPSQI >5;Duration of thecondition: NR.

84 3 groups(n28 foreach group):acupressuregroup (ACU);shamacupressuregroup (SHAM),and controlgroup (CON).

Both ACU &SHAM groups:5 min finger &10 minacupointmassage,Rx 1e10 pm,5 per wk for3 wks (total15Rx); ACU: realacupoints withDeqia. SHAM:1 cm to 3cunb

away from trueones. CON: talkonly.

GV20,GB20, Anmian,Shenmenin the ears andhands.

Subjective:PSQI Chineseversion.

Pre- andpost-intervention.

Significantdifferences inPSQI scores ofnocturnalawakening andnight wakefultime in the ACUgroup incomparison tothe other twogroups, whichdid not havestatisticaldifference.However, therewereimprovementsin all groups.

84 out of 124subjects finishedthe project.Each group had 6dropouts, other22 unfinishedNR.

ui (2003,China)16

CT: Groupassignmentmethod: NR;Control:medicationcontrol;Blinding: Notblinded; Riskof bias:category C.

Age: 28e67 yr;Gender:F:M58:72;Referral: outpt;Sleep difficulty:insomnia of TCMDx interior-stirring byphlegm-heat,self-report SE

75% withoutmed; markedlyeffectivedSEimprove by10e20% withoutmed; improvedeSE improve by

da Silva (2005,Brazil)17

CT: Groupassignmentmethod:participation dayof the week;Control: study/educationcontrol; Blinding:Not blinded; Riskof bias: categoryC.

Age: 15e39 yr;Gender:Females;Referral:pregnant womenattendingprenatalprogram; Sleepdifficulty:insomnia due topregnancy andnot takinghypnotics;Duration of thecondition:15e30 wks ofgestation.

22 >2 groups:acupuncture(ACU, n17initial); control(CON, n13initial).

Both groups:sleep hygieneeducation;ACU: plusacupuncture1e2x/wk for8 wks, eachsession average12 needles for25 min, Deqiwithmanipulation.Total 8e12Rx.CON: educationonly.

HT7, PC6, GB21,GV20, CV17,Anmian, andYintangoptional (up to4 points eachsession).

Subjective:numerical ratingscale from 0 to 10for severity ofinsomnia.

Baseline, q2wks(5 evals).

The change inthe insomniascores duringthe course ofacupuncturetreatment wassignificantlyhigher than thecontrol group;no difference innew-bornbabies data andno severe sideeffects.

Dropouts (27%):5 from ACUgroup, 3from CON group.

Gao (1995,China)18

CT: Groupassignmentmethod: NR;Control: a.bodyacupuncture,b. medication;Blinding: none;Risk of bias:category C.

Age: 18e62 yr;Gender:F:M76:180*;Referral: outptclinic; Sleepdifficulty:insomnia;Duration of thecondition: 5 daysto 21 yr.

258* 3 groups:auricularseedspressure(AUR,n128);bodyacupuncture(BOD,n65);medications(MED,n65).

AUR: auricularvaccaria seedspressing 2e3xper day, each 3e5 min (qhsmore), everyother or 2 dayschange; 1e12Rx.BOD:individualizeddaily bodyacupuncture 20e30 min; 5e20 Rx.Both groups: Nomeds. MED:Surazepam 2e4 mg qhs; 10days1 course.

AUR: Main:shenmen, HT,brain; adjunct(1e2): SP, LR,GB, ST, KI.BOD:individualizedtreatments.

Subjective:cureddshortenedsleep onset,symptomsresolve,and sleep 6e8 hper night;improveddimprovedsymptoms, sleep4e5 h per night;no responsednosymptomimprovements;sleep

able 3 (continued)

uthorear,rea)


im (2004,Korea)19

RCT: Groupassignmentmethod: randomdigits; Control:shamacupuncturecontrol; Blinding:independentevaluator singleblinded, noblinding processevaluationreported; Risk ofbias: category B.

Age: RA65.19.0, SA68.310.4;Gender:F:M13:17;Referral: strokeinpatients; Sleepdifficulty:persistentinsomnia > 3nights in a row,ISI > 15, patientson hypnoticswere excluded.Duration of thecondition: poststroke-onset.

30 2 groups (n15each group): realacupuncturegroup (RA); andshamacupuncturegroup (SA).

Real:intradermalacupunctureneedle tapeddown for 2 days;Sham: samepoints andtaping butneedles did notpenetrate theskin. Total 1 Rx.

b/l HT7 andPC6.

Subjective:Questionnaires,Insomnia SeverityIndex (ISI), andAthens InsomniaScale.

Morning before,1 and 2 daysafter.

All assessedsleep outcomesimprovedsignificantly inthe RA groupcompared to theSA group, exceptfor sleep latencyand ease offalling asleepafter wakening.

(2005,China)20

CT: Groupassignmentmethod: NR;Control: shamand medicationcontrol; Blinding:single blinded(subjects), noblinding processevaluationreported; Risk ofbias: category B.

Age: 58e79 yr;Gender:F:M28:22;Referral:outpatientacupunctureclinic; Sleepdifficulty:primaryinsomnia*Duration of thecondition: 2months to 9 yr.

50 2 groups (n25each): treatmentgroup and controlgroup.

Treatment:gingkgo leafpreparationtaped onacupoint,VitC po daily;Control: starchtaped on thesame acupoint,estazolam(regulardosage) podaily. Bothgroups: tapechange every 3days, total 7Rx.

CV8 Subjective:SEsleep time/bed time (%). 5stages: stage 0:SE>80%; stage 1:SE 70e80%; stage2: SE 60e70%;stage 3: SE 50e60%; stage 4 SE40e50%; stage 5SE

Lian (1990,China)21

CT: Groupassignmentmethod: NR;Control:medicationcontrol group;Blinding: none;Risk of bias:category C.

Age: mean 21-over 51; Gender:F:M92:68;Referral: outpts;Sleep difficulty:insomnia;Duration of thecondition: 20days to 7 yr.

160 2 groups (n80each): auricularpressing (AP)group andmedication (MED)group.

AP: semenvaccariae seedstaped atauricular pointsbilaterally,changed every 3days, patients topress the points1 h before sleepqhs, total 30days. MED:diazepam 10 mgqhs30 days.

b/l ear points:shenmen, HT,LR, Endocrine,sub-cortex,sympathetic,cervicalvertebrae.

Subjective:Clinical effectivecriteria:cureddsleep well7e8 h/night withsymptomsdisappeared;improveddsleep 4e5 h/night;ineffectivedinsomnia notameliorated.

Post-treatments. During initialstage, MED wasmore effective,but efficacyreduced withtime; on thecontrary, APcould beenhanced withtime. At the end,there wassignificantlyincreasedresponse rate inthe AP group.

Suen (2002,Hong-Kong)22

CT: Groupassignmentmethod: NR;Control: a. seedtaping withpressure, b. nopressure shamcontrol; Blinding:double blinded(both evaluatorandparticipants), noblinding processevaluationreported; Risk ofbias: B.

Age: 60 yr(mean 81.7);Gender: F:M110:10;Referral: 12homes for theelderly; Sleepdifficulty: 3nights qw;actigraphicSE20 yr.

120 3 study groups:Junci Medulla (noweight or activephysiology-sham,n30); SemenVaccariae(pressure, n30);experimental:auricularmagnetic pearls(n60).

Subjects wereasked not totake anysleeping pillsduring the studyperiod; all threegroups hadtaping ofmaterial to theauricularacupoints onalternating earevery 3 days for3 wks total.

Ear points:Shenmen, HT, KI,LR, SP, occiput,sub-cortex.

Objective: wristactigraphymonitoring,Subjective: Sleepquestionnaire(including dailyhabits that mightpotentially affectsleep), and sleepdiary filled out bystaff of the homesfor the elderly.

3 days baseline,3 days during theintervention, 3days post-intervention.

1. Significantimprovement inactigraphic SE,and nocturnalsleep time onlyin theexperimentalgroup. Inaddition, asignificant Ysleep latencyand wake aftersleep, [ totalwake time.There was nodifference b/wthe 2 controlgroups. 2. TCMdx did not affectRx results; 3. theyounger age thebetter result.

Dropouts wereall replaced;Suen 200327

followed 15subjects at 1-,3-, and 6-monthand showedsustainedeffects.

(continued on next page)

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Table 3 (continued)

Author(year,area)


Tsay (2004,Taiwan)23

CT: Groupassignmentmethod: NR;Control: a. TEAS:transcutaneouselectricalacupoint stim,b. usual care;Blinding: doubleblinded(subjects, careproviders andinterviewer),blinding processevaluation NR;Risk of bias:category B.

Age:58.1612.19;Gender:F:M66%:34%;Referral: ESRDoutpt on HD 3months, c/ofatigue, with nomajor chronicand psychconditions, ordementia; Sleepdifficulty: PSQI5, BDI 10;Duration of thecondition: NR.

106 3 groups (n36to start witheach group):acupressure(ACU), TEAS,and usual carecontrol.

Both ACU &TEAS: 3x/wk4wks (12 Rx),each session ofrelaxationmassage(5 min)Rx3 min at eachacupoint. ACU:fingeracupressure (3e4 kg) with Deqisensation; TEAS:2/100 Hz stim.

b/l KI1, ST36,GB34, SP6.

Subjective: PiperFatigue Scale,PSQI, and BDI.

Pre-baseline,11 data pointsduring Rx, andpost-intervention.

No differenceb/w ACU andTEAS groups,both significantlybetter thancontrol group infatigue level,PSQI total score,self-reportedsleep quality,and depressionscores.

Dropouts: 1 inACU, 1 in usualcare control.

Tsay (2003,Taiwan)24

CT: Groupassignmentmethod: NR;Control: a. shamcontrol, b. usualcare; Blinding:double blinded(subjects, careproviders andinterviewer), noblinding processevaluationreported; Risk ofbias: category B

Age:55.5212.98;Gender:F:M56:42;Referral: ESRDoutpt on HD,with no majorchronic andpsychconditions, ordementia; Sleepdifficulty: PSQI 5; Duration ofthe condition:NR.

98 3 groups (n35each to startwith): realacupressuregroup, shamacupressuregroup, and usualcare controlgroup.

Both real andsham: 3x/wk4wks (12 Rx),each session ofrelaxationmassage 5 minplus acupressure3 min each point(total 14 min);finger pressureof 3e4 kg. Real:at acupoints;Sham: 1 cm awayfrom real points

HT7, KI1, andear Shenmen

Subjective: PSQI,subject sleep log,Medical outcomestudy SF-36.

Pre-treatment;8 data pointsduringintervention;post-treatment.

Acupressuregroup didsignificantlybetter than thecontrol; nodifference b/wreal and sham;quickimprovementwas observedafter 2e3sessions.

Dropouts: 3 insham, 4 incontrol.

82W.Huangetal.

Wang (2006,China)25

RCT: Groupassignmentmethod:computerizedrandom numbergeneration;Multicenter: 3;Control:medicationcontrol group;Blinding: none;Risk of bias:category C.

Age: mean16e75; Gender:F:M108:72;Referral: outpts;Sleep difficulty:primaryinsomnia withsleep latency >30 min morethan 3x/wk, PSQI> 7; Duration ofthe condition:NR.

180 2 groups (n90each): rollingneedle andmedication.

Rolling needle:slow rolling 10for 15e20 min toproduce skinredness, 5x/wkfor 4 wks (20 Rx),while taperingdown/offsleepingmedications;medicationgroup:Clonazepam4e6 mg qhs.

Along the backBladder meridian1st and 2nd line(rolling up todown) and GVMeridian (rollingdown to up).

Subjective:Spitzer QoLIndex; clinicaleval: cured e[ SE>75% withdisappearance ofsymptoms;improvede[sleep durationand [ SE 25e74%,withimprovement ofsymptoms; noeffecte[SE5 h/night,alleviation ofsymptoms;ineffective: noevidentimprovements.

In the one casereported, 6months f/u.

There wassignificantdifference oftherapeuticeffects in thetreatment groupcompared to the2 control groups.There was nostatisticaldifference b/wthe 2 controlgroups.

All abbreviations, except for those representing different study groups as indicated in the table, are listed in the Appendices.a Deqi: a term in acupuncture to describe the sensation of feeling energy flowing through the inserted needle. See page 95 for detail and discussion.b cun: a measurement used in acupuncture to find acupoints in relation to the patients own body size. For instance, the distance between the centre of the patella and the lateral

malleolus is 16 cun and this 16 cun can be used to find acupoints on the legs. Here, 3 cun is 4 finger breadths.

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3. Control groups: 5/12 employed sham control being more effective. However, without

84 W. Huang et al.(with or without other controlgroups)15,19,20,22,24; other studies include usualcare,23,24 conversation,15 education,17 medi-cation,16,18,20,21,25 or other activetreatments.22,26

4. Blinding process: 3/1222e24 double-blinded and3/1215,19,20 single-blinded, but none of thesestudies reported an evaluation process of theadequacy of the blinding.

5. Subject age range: above 15 years old.6. Sample size: 22e258.7. Insomnia conditions:

a. Primary insomnia (n2).20,25b. Comorbid insomnia (n4): e.g., post-

stroke,19 pregnancy,17 and end-stage renaldisease (ESRD) patients on hemodialysis(HD).23,24

c. Unspecified insomnia (i.e., neither primaryor comorbid specified) (n5)15,18,21,22,26: 2of which employed TCM diagnoses duringtreatments.18,26

d. Insomnia associated with a particular TCMdiagnosis (n1): e.g. interior-stirring byphlegm-heat.16

8. Study quality: 6 studies15,19,20,22e24 with cate-gory B evidence, and 6 studies16e18,21,25,26 withcategory C evidence.

9. Acupuncture treatments: techniques varied,including regular body acupuncture,16,17 roll-ing needle or intradermal needle,19,25 acu-point taping with herbal preparation,20

auricular treatment with seed pressing ormagnetic pearls,18,21,22,26 and acupres-sure.15,23,24 Points varied from 1 to entiremeridian, including body or auricular treat-ments. Most of these studies used a standard-ized treatment paradigm, except for threestudies17,18,26 which employed an individual-ized approach. Duration ranged from 1 to 30treatments.

10. Sleep outcomes: Most used subjective evalua-tions alone (n11), e.g., single administrationsleep questionnaires, including the PittsburghSleep Quality Index (PSQI),15,17,19,22e24 someform of a clinical global impres-sion,16,18,20,21,25,26 and sleep diary.22,24 Only 1study22 also used actigraphy as an objectivesleep evaluation; none used polysomnography(PSG).

11. Effects of acupuncture for sleep:a. Compared to education control: da Silva

et al.17 treated pregnancy insomnia withsleep hygiene education alone versusa combination of acupuncture and educa-tion; they showed the combination therapya sham acupuncture group, one cannotconclude whether this additional effect wasdue to acupuncture itself or from the moti-vational/placebo effects due to theperception that something had been per-formed by physicians to help.

b. Compared to medication control: medica-tions used for comparison in the includedstudies were benzodiazepine receptoragonists, e.g., estazolam,16,20 sur-azepam,18 diazepam.21 These studies allshowed better treatment effects ofacupuncture compared to medications,although Lian et al.21 indicated that medi-cation had shorter duration of treatment toachieve benefit and acupuncture requiredmore treatments to surpass the effective-ness of medication.

c. Compared to sham control: results aremixed. Chen et al.15 used acupressure atsham versus real acupoints, Kim et al.19

used sham versus real acupuncture nee-dles, Li et al.20 used flour (sham) versusGingkgo leaf preparation (real) taping atacupoint, and Suen et al.22 used JunciMedulla (sham) versus magnetic pearls(real) auricular treatments; all showedsignificant sleep improvements in the realgroups. However, Tsay et al.24 showed nodifference between sham and realacupressure, although both groups signifi-cantly improved sleep when compared tothe usual care control.

d. Compared to other types of control: Gao18

compared auricular and body acupunctureand showed better clinical effectiveness inthe auricular group. Tsay et al.23 comparedacupressure and transcutaneous electricalacupoint stimulation (TEAS) and showed nodifference between the two groups,although both did significantly better thanthe usual care group. Yang26 compared herb-soaked seeds at specific acupoints accordingto TCM diagnoses and two controls withregular Semen Vaccariae seeds at specificversus non-specific acupoints, and demon-strated stronger treatment effects withherb-soaked seeds but with no differencebetween the two control groups.

12. Maintenance of efficacy: only 2 studies25,27

reported follow-up periods of 3e6 months;both maintained the improvements found atthe end of intervention. Anecdotal cases18

reported beneficial effects lasting for 2 yearsat follow-up.

Case series of acupuncture in treating et al.40 used PSG recording and showedsignificant improvement in sleep onset

sham; one study, although showing significant

Acupuncture for insomnia 85insomnia (details see Table 4)

1. Included studies: 18.28e45

2. Subject age range: 12e83 years old.3. Sample size: 16e2485.4. Insomnia that was treated by acupuncture:

a. Primary insomnia (n2)32,34: both employedTCM diagnoses during treatments.

b. Comorbid insomnia (n2): e.g., AIDS,35anxiety.40

c. Unspecified insomnia (i.e., neither primary orcomorbidspecified) (n13)28e31,33,36e39,41,43e45:6 of which had TCM diagnoses.28,30,36,38,44,45

d. One study used the same acupuncturetreatments for patients with either insomniaor excessive sleep.42

5. Study quality: all studies with category Cevidence.

6. Acupuncture treatments: techniques varied;half of the studies used auricular treatments,e.g., seeds taping and pressure applica-tions,31,36,42 in combination with education32

or auricular blood letting,29 lidocaine injectionat auricular points,33 laser irradiation,44 incombination with body acupuncture.35,38 Theother half used body acupuncture alo-ne,30,37,39e41 in combination with plumblossom needle tapping45 or adjunct thera-pies,43 or combination acupuncture (e.g.,body, scalp and moxibustion).28,34 Pointsvaried from 2 to entire meridian. All except 4studies37,40,41,43 reported individualized treat-ment paradigms. Duration ranged from 3 to 60treatments in the reported data.

7. Sleep outcomes: most of these stu-dies28e34,36e39,41e45used some form of a clinicalglobal impression alone (n16). Only 2 st-udies35,40 used objective sleep evaluations, PSGor wrist actigraphy, in addition to single admin-istration questionnaires including PSQI.

8. Effects of acupuncture for sleep:a. Case series: demonstrated positive treatment

effects of acupuncture in reducing sleeplatency,36,40 improving sleep and wake ratio/sleep efficiency,35,39,40 increasing sleep dura-tion and quality28e30,32,33,35e37,39e45 and reso-lution of insomnia symptoms28e30,37,39e43,45

using clinical global impression. Interestingly,the two studies that used objectivemeasurements showed different results insleep latency. Phillips study35 in AIDS patientsused wrist actigraphy and showed no signifi-cant difference in sleep latency afteracupuncture treatments; while Spenceimprovements over usual care, reported absence ofdifferences between real and sham acupressure.However, in this study, relaxation massage was alsoapplied in the sham group, which may have exertedtreatment effects. Furthermore, the shamacupointswere only 1 cm away from the true meridians, whichrepresents a small distancebetween sites, especiallywhen using finger acupressure technique. Becausewedonot knowhow far away the treatment gradientwould extend from the true acupoints (in distance ordepth), manipulations such as finger pressure maystill have elicited physiological effects in this study.This could explain why another study15 using thesame technique found significant differencesbetween real and sham acupressure treatments. Inthat study, the sham points were up to 3 cun (aboutfour finger breadths) away from the true acupointson the body. The inconsistencies of choosing shamacupoints may have led to inconsistent results.Another relevant study was Suen et al.,22 wholatency in insomnia with anxiety as a comor-bid condition. The difference could be due todifferent comorbidities, or different out-come measures with different measurementsensitivity.

b. Case series with controls: Lu34 showedsignificantly better outcome with acupunc-ture, compared to the combination ofWestern and herbal medications.

c. Wu42 used the same primary acupoints totreat either insomnia or excessive sleep andshowed improvements in both groups with85% and 100% effective rates, respectively.

9. Maintenance of efficacy: 4 studies33,34,41,45

reported follow-up periods of 2months to a year;all maintained the improvements found at theend of intervention. Anecdotal cases29,36,37

reported beneficial effects lasting for 2e3.5years at follow-up.

Discussion

What are the methodological limitations ofexisting studies of acupuncture treatmentfor insomnia?

Inconsistent sham controls and deficiency inblindingVery few studies15,19,20,22,24 have used sham controlgroups. Four of these studies demonstrated positiveimpact on sleep with real treatments relative to

24

Table 4 Case series of acupuncture in treating insomnia

Author(year, area)

Study design Population N Treatment Acupoints Eval F/U Results Notes

Cheng (1986,China)28

Case series:Control ofconfounders:no. Exposurebias: yes.Attrition bias:yes.Measurementbias: yes. Risk ofbias: category C.

Age: 12e83 yr;Gender:F:M892:1593;Referral: outptssince 1954;Sleep difficulty:insomnia ofvarious etiologyand divided into5 TCM dx: a.deficiency of HTand SP; b. HTand GB Qideficiency; c. KIdeficiency; d.disharmony b/wST and mid-Jiao;e. upwardinvasion of LRYang; Durationof thecondition: mean149 days.

2485 Dailyacupuncturewith manualstimulation andDeqi, needlesretained for 20e40 min,12e15x1course, plusmoxibustion ofselected pointsin certainconditions. TotalRx NR.

Main: HT7*,GB12, ST36.Adjunct: a. PC7,SP6; b. GB40,GV20*; c. KI6,KI3; d. CV12,PC6; e. LR2,BL18, CV20.*20 minmoxibustion inlong-termdeficientpatients.

Subjective: Clinicalevaluation:cureddnormal sleepwith resolution ofdaytime symptoms;improveddsubjectiveimprovements in sleepquality and quantity aswell as someamelioration ofsymptoms;ineffectivedno change.

After onemonth

All 327 patientswho were onhypnotic medswent off medsafter 10 Rx.Simple insomniawith averageddisease course29days, thetreatmenteffective ratewas 74.65%;Other etiologiesaveraged 167days, theeffective ratewas 41.18%statisticallysignificantdifference b/w.

Prior to thestudy, 1274cases failed torespond ormaintain theresponse tohypnotic meds,herbs, orphysicaltherapy.

Dang (1995,China)29

Case series:Control ofconfounders:none. Exposurebias: no.Attrition bias:yes.Measurementbias: yes. Risk ofbias: category C.

Age: 16e68 yr;Gender:F:M30:28;Referral:outpts; Sleepdifficulty:insomnia;Duration of thecondition: 7days to 30 yr.

58 Bloodletting atauricular tip;then other b/lauricularacupoints withvaccaria seedstaping, pressed5e6 x/day, moreintensity at qhs,once a weekvisit to changeout the seeds.All sleep relatedmeds arestopped duringtreatment.5Rx1 course(Total NR).

Auricular tipplus thefollowingauricularacupoints:shenmen, sub-cortex,occipital, HT,shenshuai;adjunct pointswere used ifwith symptoms,e.g., LR, GB, KI,ST.

Subjective: Clinical eval:cureddnormal sleepwith no recurrence afterstop of Rx; improvedesignificant improvementswith >5 h per nightsleep, slight recurrenceafter stop of Rx butimproved withreinforcement Rx;ineffectivedno obviousimprovements.

One casereported in thearticle had 2 yrof f/u.

38 cases cured;19 casesimproved; 1case noresponse.

Unknown totalRx that wereneeded, forinstance for 7-day insomniaversus for 30 yrof insomnia.

86W.Huangetal.

Gao (1997,China)30

Case series:Control ofconfounders:no. Exposurebias: yes.Attrition bias:no.Measurementbias: yes. Risk ofbias: category C.

Age: 16e72 yr;Gender: NR;Referral: outptform June 1991to May 1994;Sleep difficulty:insomnia dividedinto 5 TCM dx: a.deficiency of HTand SP; b.incoordinationb/w HTand KI; c.insufficiency ofHT and GB; d.disturbance of LRYang due toemotionaldistress; e.phlegm heat;Duration of thecondition: 7 daysto 6 yr.

288 Dailyacupuncturewith needlesretained for30 min, 25 minof which theneedles weremanuallymanipulated.Total Rx NR.

Main: HT7, KI7;Adjunct: a.BL15, BL14,BL20; b. BL15,BL23, KI3, SP6;c. BL15, BL19,PC7, GB40; d.BL18, PC5, LR3;e. BL21, ST36.

Subjective: Clinicaleffects: cureddsleep 7e8 h/night with resolutionof all symptoms;excellentd6e7 h/nightwith resolution of allsymptoms;improveddsleep 5 h/night with occasionalsymptoms; no effectenochange or worse.

In the one casereported, f/u 1/2 yr.

90.96% casecured, 5.56%cases withexcellenteffect, 2.08%cases improved,1.39% with noeffect.

Gao (1996,China)31

Case series:Control ofconfounders:none. Exposurebias: yes.Attrition bias:yes.Measurementbias: yes. Risk ofbias; category C.

Age: NR;Gender: NR;Referral:outpts; Sleepdifficulty:insomnia;Duration of thecondition: NR.

25 Auricularvaccaria seedstaping change Qdwith alternatingear, pressed 3e4x/day, eachtime 1e2 minwith moderatelystrongstimulation. 10changesonecourse (10 days).Resting for 3e5days. Then nextcourse if needed.

Ear points:Shenmen, HT,sub-cortex(which can beeliminated if nopain onprobing).Additionalpoints (2e3):brain,sympathetic,endocrine, SP,LR, ST, KI.

Subjective: Clinicalevaluation details NR.

18 cases curedwith 1 course; 3cases cured with2 courses; 2cases received 3courses but stillwith 2 h of sleeponset latency; 2cases noresponse.


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Table 4 (continued)

Author(year, area)


Ju (1997,China)32


Age: 14e55 yr;Gender:F:M32:21;Referral:outpts; Sleepdifficulty:primaryinsomnia with 4TCM dx-a. firedue to LRdepression; b.phlegm heat; c.excessive firedue to Yindeficiency; d.deficiency of HTand SP; Durationof thecondition: 2months to 11 yr.

53 Education:modification oflife style, suchas the use oftea, coffee.Auricularvaccaria seedstaping: one ear/alternating q5days, massageeach point 2e3x/day, each atleast 50 times,more qhs, tillDeqi. 10 Rx1course. Total RxNR.

Main: Shenmen,sub-cortex,endocrine,brain,sympathetic;Adjunct:according toTCM dx-a. LR,GB; b. HT, SP,ST; c. KI, BL; d.HT, SP, SI. Iffemale add JingGong.

Subjective: Clinical eval:cureddsleep return topre-morbid condition;effectivedboth sleepduration and depthimproved;ineffectivedno changeof insomnia symptoms.

NR 29 cases cured,19 caseseffective, 3casesineffective.

2 dropouts.

Lee (1977,USA)33

Case series:Control ofconfounders:no. Exposurebias: yes.Attrition bias:no.Measurementbias: no. Risk ofbias: category C.

Age: 26e69 yr;Gender:F:M7:9;Referral: outptswith insomnia aschief complaint,with or withoutmedicalcomorbidities;Sleep difficulty:sleep 3e4 h/night withdaytimesymptoms;Duration of thecondition: 2 wksto 34 yr.

16 All sleep medsdiscontinuedprior to thetreatments.Lidocaineinjection atauricularacupoints(alternatingear); frequencyinitially 3x/wklater changeddepending onresponses.Patients to beactive physicallyfor about20 min post-injection.

Ear points:Main: HT, KI,adrenal, sub-cortex,endocrine, TH,Shenmen;adjunct:sympathetic,occiput, GBdepending onindividualpatient.

Objective: heart rate;Subjective: Sleepduration.

Pre- and posttreatments, 3months f/u.

Total Rx varyfrom 2 to 28,mostly below 15(only one28)dnotcorrelated withseverity ofinsomnia. Allpatientsreportedsubstantialimprovement.68.7% cases had>7 h sleep pernight withoutmeds whichsustained duringf/u and wereconsidered to becured.

Hypothesis wasthat lidocaine(blockingsensory input)is good forrelativeexcess of Yangand also goodfor those whodid not respondto regularacupuncture.

88W.Huangetal.

Lu (2002,China)34

Case series:Control ofconfounders:comparableb/w groupacupuncture(ACU) and groupmedication(MED) butstatistical dataNR. Exposurebias: unknown.Attrition bias:unknown.Measurementbias: yes. Risk ofbias: category C.

Age: 53e79 yr;Gender:F:M35:48;Referral: outpt;Sleep difficulty:primary insomniaof 4 types TCMdx: a. deficiencyof HT and SP(n25 vs. 11), b.incoordination ofHT and KI (n24vs. 10), c. LR fireflaming up (n17vs. 8), d.disharmony of ST(n17 vs. 6);Duration of thecondition: 1e20 yr.

118(ACU83;MED35)

ACU: TCM Dx-specific bodyand scalpacupuncture,with manualmanipulationandmoxibustion* incertain casesqd10d1course, total of30Rx. MED: 2.5e5.0 mg qhs ofnitrazepam and10 ml bid of AnShen Bu Nao Ye(herb).Treatmentduration NR.

All: scalp MS1,MS2, plus a.scalp anterior2nd line, bodyBL20*, BL*, HT7,ST36. b. scalpMS3, body KI3,HT7, PC7, LR3.c. scalp MS5,body LR2, GB44,20, HT7. d. scalpMS5, body CV12,ST40, 45, SP1.

Subjective: Clinicaleval: Cureddsleepnormally with norecurrence duringf/u; markedlyeffectivedsleepnormally but withoccasional insomnia;effectiveds/simproved; noeffectdnoimprovement at all.

f/u 1 yr. There wassignificantdifference ofeffective ratesb/w groups.There was also atendency tofavor excesssyndromes thandeficiencysyndromes.

Phillips (2001,USA)35

Case series:Control ofconfounders:no. Exposurebias: yes.Attrition bias:no.Measurementbias: no. Risk ofbias: category C.

Age: 29e50 yr;Gender: NR;Referral: AIDSsupportorganization anda privatemedical clinic;Sleep difficulty:with sleepdisturbances 3nights/wk andPSQI > 5.Duration of thecondition: NR.

21 Individualizedacupuncture(combined bodyand auricular)with 10e15needles, for 30e45 min, Deqisenses, 2evenings/wk5wks(delivered ingroup sessions).Total of 10 Rx.

Body: HT7, SP6,KI3, PC6;auricular:Shenmen, HT,LU,sympathetic.Adjunct: pointsare selected ifwith peripheralneuropathy andpain.

Objective:Wrist actigraph;Subjective: PSQI,CSQI, visual analogpain rating anddemographic dataform.

2 nights beforeand 2 nightsaftertreatments.

In addition tosubjective sleepimprovements,significantimprovementsseen inactigraphy TST,# of min spentawake, and SE.Not significant insleep latency, #of mid-sleepawakenings, andWASO.

Dropouts: 1 diedand 1 left due todistance. Painmeasurementcomparison NR.


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Table 4 (continued)

Author(year, area)


Qiu (1996,China)36


Age: NR;Gender: NR;Referral:outpts; Sleepdifficulty:insomnia with 4TCM dx-a.deficiency of HTand SP; b.disharmony ofHT and KI; c.deficiency of HTQi; d. LR Qistagnation;.Duration of thecondition: NR.

65 Auricularvaccaria seedstaping oneear/alternatingq3e5 days,massage eachpoint 25 x/daytill Deqi. 10Rx1 course.Total Rx NR.

Main: Shenmen,occiput, HT,sub-cortex,insomnia;Adjunct: a.SP, SI; b. LR,KI; c. LR, KI,GB; d. LR, TE

Subjective: cureddsleeponset normal,sleep normal;significantlyimproveddsleeponset improved,sleep normal buteasy midnightwakening;improveddsleepimproved;ineffectivednoobviousimprovementsafter 1 course.

In the onecase reported,2 yr f/u with noreoccurrence.

32 cases cured,18 casessignificantlyimproved, 11cases improved,4 casesineffective andwere stoppedafter 1 course.

Ren (1985,China)37


Age: NR;Gender: NR;Referral: outptclinic; Sleepdifficulty:insomnia;Duration of thecondition: NR.

86 Needling 2acupoints with1 needle andmanuallystimulated toget Deqisensation, thenthe needle wasretained for 5e15 min withmanual stimq5 min; Rx qd7days1 course,then 3 days ofrest. In the onecase reported,total 5 courses;others NR.

PC7 towardsTE5.

Subjective: Clinicaleffects:curedd>6 h/nightsleep with completerelief of symptoms;markedlyimprovedd>4 h/nightsleep, with markeddiminutionof symptoms;improveddable toget some sleep butawakens often withsome improvementof symptoms;unimproveddnochange.

In the onecase reported,f/u 3.5 yr.

Of the 86 cases,39 cured, 36markedlyimproved, 11improved.

90W.Huangetal.

Shen (2004,China)38


Age: 17e54 yr;Gender:F:M94:106;Referral: outptclinic; Sleepdifficulty:insomnia,primary n156and secondaryn44, dividedinto 4 TCM dx: a.incoordinationb/w HTand KI; b.ST disorders; c.deficiencysyndrome; d.deficiency of HTand SP; Durationof the condition:2e245 days.

200 Combination of1. auricularpressure and 2.acupuncture(for cases withduration of morethan 2 months).1. Vaccariaseeds tapingalternating earq3e4 d, pointspressed 3e4x/day. 2. Daily Rxwith manualmanipulation,needles retainedfor 5e20 min.Both: 5 days1course; total 3e4 courses (15e20Rx).

Main earShenmen, HT,Shenshuai,brainstem.Optional ear LR,ST, HT, KI,endocrine. a.HT7, SP6; b.BL21, ST36,Yintang, GB20,HT7; c. Anmian,SP6, HT7, BL23;d. ST36, GV20,Yintang,Anmian.

Subjective: Clinical evaldetails NR.

Post-treatments.

75% cases werecured, 15% caseswere effective,7% wereimproved, and3% wereineffective.Better results inpatients withshorter durationof disease, butdetailed analysisNR.

Shi (2003,China)39

Case series:Control ofconfounders:none. Exposurebias: yes.Attrition bias:yes.Measurementbias: no. Risk ofbias: category C.

Age: 18e69 yr;Gender:F:M17:11;Referral:outpts; Sleepdifficulty:insomnia;Duration of thecondition: 3months to 1 yr.

28 Individualizedbodyacupunctureaccording toTCM Dx.Detailedfrequency andtotal Rx NR.

Main points:HT7, GB13, SP6,PC6. Adjunctpointsdepending onTCM diagnoses(5 examplesgiven): e.g.,LR3, LI4, KI7,ST36, LU7, BL20.

Subjective: Clinicaleffects*: cureddgrade1 sleep with no med,symptoms resolved;markedlyeffectivedgrade 2 sleepwith no med, symptomsgreatly improved;improveddgrade 3 sleepwith over 3/4 Y of meddoses, and symptomsimproved; faileddstage4 or 5 sleep, meddependence, symptomsstill exist.

In the one casereported, 6months f/u.

17 cases cured,7 casesmarkedlyimproved, 4cases improved,0 failed.

*5 grades ofsleep quality byWHO standard:1: SE 70e80%; 2:SE 60e70%,sleep onsetdifficulty; 3: SE40e50%, mildsleep dis; 4: 40e50%, moderatesleep dis; 5: 30e40%, severesleep dis.


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Table 4 (continued)

Author(year, area)


Spence (2004,Canada)40

Case series:Control ofconfounders:yes. Exposurebias: yes.Attritionbias: NR.Measurementbias: no. Riskof bias:category C.

Age: 18e55 yr;Gender:F:M11:7;Referral:volunteers;Sleep difficulty:insomniaassociated withanxiety, scoring>50 on the ZungScale but notmeeting DSM-IVcriteria foranxiety dis.Duration of thecondition: atleast 2 yr.

18 2x/wkacupuncture5wks (total of 10Rx)

NR Objective: PSGrecordings, urine aMT6smeasurements(metabolite ofmelatonin); Subjective:questionnaires onsleepiness, fatigue,alertness, anxiety,depression; complexverbal reasoning task.

Before andaftertreatments.

Significant[melatoninsecretion withimprovementsin PSG sleeponset latency,arousal index,TST, SE, stage 3sleep; reductionin morningfatigue andsleepiness,anxiety, anddepression; anddecreasedperformancetime forcomplex verbalreasoning task.

Also seendecreaseddaytimealertnessehypothesizedas being moreadaptive.

Wang (1992,China)41

Case series:Control ofconfounders:no. Exposurebias: yes.Attrition bias:no.Measurementbias: yes. Risk ofbias: category C.

Age: 16e63 yr;Gender:F:M21:29;Referral: outptclinic; Sleepdifficulty:insomnia;Duration of thecondition: 0.5month to 13 yr.

50 All sleep medswerediscontinuedprior to Rx. Dailyacupuncturewith needle tipsreachingperiosteum andneedles retainedfor 20 min;10x1 coursewith 3 days in b/w courses. TotalRx NR.

CV20, andSishencong.

Subjective: cureddsleep[ of 4 h/night, and>6 h/night at 2 monthsf/u, with all symptomsrelieved. Excellentdsleep [ of 3 h/night, and>4 h/night at 2 monthsf/u with remarkedlyimproved symptoms;improvedd temporaryimprovements of sleepand symptoms with Rx;no effectdno notedimprovements.

Post-treatmentsand f/u at 2months.

40% cases cured,46% cases withexcellentresponse, 10%cases improvedduringtreatments, 4%cases with noresponse.

92W.Huangetal.

Wu (1998,China)42

Case series:Control ofconfounders:none. Exposurebias: yes.Attrition bias:yes.Measurementbias: yes. Risk ofbias: category C.

Age: 19e68 yr;Gender:F:M22:38;Referral:outpts; Sleepdifficulty: 2groups:insomnia (INS,n40) andexcessivedaytimesleepiness (EDS,n20); Durationof thecondition: 3days to 5 yr.

60 Auricularvaccaria seedstaping, pressed5e6 x/day, eachtime 2e3 min(until feelingwarm or barelypainful), noheavy massage.QOD alternatingear. 3changes1course. 1e3courses (total3e9 Rx). Nomedicationduring Rx.

Main: HT,Shenmen,endocrine,sub-cortex.Additionalpoints wereused onlywhen verytypicalsymptomsoccur: LR,Jiang yagroove, ST,KI, LI.

Subjective: INS:cureddsleep >7 hper night withdisappearance ofsymptoms;effectivedsleep >5 hper night; EDS:cureddsleep 8 h/daywith disappearance ofsymptoms;effectivedsleep about10 h/day; Both Groups:no responsedno obviousimprovements.

Two casesreported in thearticle had 2e3months of f/u.

INS: 23 casescured; 11effective; 6 noresponse; EDS:16 cases cured;4 caseseffective; 0 caseno response

Difference ofthe conditionduration b/wthe groups NR.

Xie (1994,China)43


Age: 21e48 yr;Gender:F:M67:57;Referral:outpts; Sleepdifficulty:dyssomnia failedprior therapies,including med(n92), herbaldrugs (n69), PT(n12),breathingexercises(n12);Duration of thecondition: 1 wkto 4 yr.

124 30 min Rx ofacupuncturewith manualmanipulationsq10 min, 7e10Rx1 course,rest 3 days.Total 1e4courses (7e40Rx), averaging3 courses. If noimprovementsafter 2 courses,other adjuvantmodalities wereadministered(details NR).

Main points:Sishencong,GV20; Adjunctpoints:HT7, KI3.

Subjective: Therapeuticeffects: cureddnormalsleep with resolution ofsymptoms; markedlyimprovedd[ sleep by2 h/night, significantamelioration ofsymptoms;effectivedsomeimprovements of sleepand symptoms;ineffectivedenoimprovements or short-lasting benefits.

In the onecase reported,3 months f/u.

73 cases cured,26 casesmarkedlyimproved, 10cases effective,15 casesineffective (7 ofwhich did notfinish the 1stcourse).


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Table 4 (continued)

Author(year, area)


Yao (1999,China)44


Age: 23e55 yr;Gender:F:M27:19;Referral:outpts; Sleepdifficulty:insomnia with 3types of TCM dx:deficiency of HTand SP (n18),disharmony ofHT and KI(n15), LR fireupward invasion(n13);Duration of thecondition: 1month to 12 yr.

46 Daily b/lauricularsemiconductorlaser irradiationof 1 min at eachacupoint tilla local warmsensation wasfelt, 12 Rx1course with 5e7days b/wcourses. Total of1e3 courses.

Auricular main:Shenmen,Endocrine,Sub-cortex,Brain; Adjunctpoints wereaccording toTCM diagnoses:e.g., HT, KI, SP,ST, LR.

Subjective: Clinical eval:cureddsleep >7 h/night; improveddsleep5e6 h/night;ineffectivedsleep 5 h/nightwithout med, allsymptoms resolved, andno recurrence in 6months f/u;improveddsleep 3e5 h/night without med,alleviation of symptoms;ineffectivedsleep

showed significant treatment effects when active help guide the technical directions for future

Acupuncture for insomnia 95studies used some form of a clinical globalimpression (n22) as the outcome measure, whichvaried widely. For instance, the outcome of thestudy45 using the criterion of sleeping over 5 h/night as being cured is obviously different fromthe outcome of the study30 that used the criterionof sleeping 7e8 h/night as being cured,although the reported effective rate wassimilar (94.28% versus 98.61%).

What are the factors that need to beconsidered in future research studies whenusing acupuncture to treat insomnia?

Acupuncture has great potential to be used totreat insomnia, although the support is limited bythe quality of current available studies. Futurevigorous research is needed to clarify acupunctureeffects and the clinical indications. In order totreatment (magnetic pearls) was compared to sham(Junci Medulla). However, Suen et al. also reportedno difference when Semen Vaccariae (typically usedin auricular acupressure treatments) was comparedto Junci Medulla (sham). These data suggest thatthere is not a simple and consistent answer regardingthe effects of acupuncture or acupressure whencompared to sham. They also raise a methodologicaland an ethical question: if sham control did betterthan usual care, no matter how the effects wereproduced, would that imply that sham acupuncturecould be used for treatment?

Another major deficit of the reviewed studieswas lack of blinding or lack of evaluation of theblinding process. Three studies22e24 were double-blinded and three15,19,20 single-blinded; no studyreported assessment of blinding effects. Obviously,in reviewing these studies, one must consider thehigh likelihood of reporting and/or evaluating bias.

Heterogeneity in study designs and outcomesInmanystudies, therewas lackofconsistentdefinitionof insomnia leading to non-specified primary versuscomorbid insomnia15,18,21,22,26,28e31,33,36e39,41,43e45

and a mixture of acute and chronic condi-tions,18,21,26,29,30,33,38,41e43,45 all of which couldcontribute to lack of equivalence across thestudies. There was also significant heterogeneityin acupuncture techniques and acupoint selec-tions, although most produced positive effects onsleep. Does this mean that the treatmentsproduce non-specific effects so that the tech-niques or acupoint choices do not matter?

Only 3 of the 30 studies22,35,40 included in thisreview utilized wrist actigraphy or PSG. Moststudies, we consider the following.

Technical factorsAcupuncture techniques: Acupuncture techniquesvary widely from study to study included inthis review (Table 2). The selection of the tech-niques depends on the practitioners preferenceand practice feasibility. Is there any acupuncturetechnique that is most effective in treatinginsomnia?

Auricular treatments were used alone or incombination with body acupuncture in 14 studies.Gao18 showed better results with auricular treat-ments compared to body treatments. Amongauricular treatments, techniques varied, such asauricular acupuncture,35 vaccaria seeds taping andpressing,18,21,26,31,32,36,38,42 magnetic pearls,22

blood letting in addition to auricular pressure,29

lidocaine injection,33 and laser irradiation.44 Allproduced similar results, except in two studieswhere better results were obtained with magneticpearls (Suen et al.22) and herb-soaked seeds(Yang26), when compared to vaccaria seeds. Ninestudies16,17,28,30,34,39e41,43,45 used mainly tradi-tional body acupuncture, with or without combi-nation of other treatments, such as moxibustion,scalp acupuncture, or plum blossom needletapping. They also showed positive treatmenteffects.

Other special treatments, such as intradermalneedle19,20,25,37 also showed good results inselected patient populations. Acupressure treat-ments,23,24 on the other hand, showed good resultscompared to usual care, but not significantly betterwhen compared to sham or electrical stimulation.

The heterogeneity of treatment techniquesposes a challenging question for future research. Areasonable recommendation would be to focus onthe most commonly used auricular treatments withor without body acupuncture to search for the besttreatment combination.

Elicitation of Deqi: All body acupuncture studiestried to elicit Deqi (da Chee, meaning getting theenergy) sensation with manual manipulations ofneedles. Is this a vital determinant of responsiveness?

In acupuncture practice, Deqi sensationdescribes patients feeling of soreness, heaviness,and many times, a radiating sensation when theneedle is inserted, which can be associated withpractitioners feeling of needle being dragged. InTCM, it is believed that when Deqi sensationoccurs, the energy is guided towards the needle,and thus better treatment response. However, it isless acceptable and tolerable by patients and also

tuddiesdie

tuddiesdie

ctu

diesy gr

96 W. Huang et al.creates difficulty in conducting studies with shamcontrol. Moreover, whether or not Deqi is the vitaldeterminant of responsiveness is still debatable.For instance, Lees study using lidocaine injection33

obviously eliminated any feeling in the acupointbut still produced treatment effects. Psychometricstudies of the sensation elicited by Deqi would aidin understanding its clinical efficacy.

Acupoints selection: From the current insomniastudies, we can see that although acupoints

Table 5 Acupoints selection in treating insomnia

Use frequency

Bodyacupuncture

Most commonly used (in >75% of sCommonly used (in 25e75% of stuSometimes used (in 10e25% of stu

Rarely used (in 75% of sCommonly used (in 25e75% of stuSometimes used (in 10e25% of stuRarely used (in

Table 6 Studies of acupuncture in treating various non-sleep conditions with sleep as a secondary outcome

Author(year, area)


Alraek(2001,Norway)46

Prospective caseseries.

Age: 18e60 yr;Gender: allfemales; Referral:subjects withrecurrent cystitis(3 episodes inpast 12 months);Duration of thecondition: NR.

67 NA Prophylacticacupuncturetreatments:2x/wk for 4 wks,each session20 min,Deqi withintermittentmanualmanipulation.

Main: ST36,SP6, SP9, LR3,KI3, BL23,BL28; Adjunct:vary dependingon TCM dx.

Open-ended,free textquestionnaire.

2 wks afterintervention.

39 reportedimprovements,including bladderemptying, bowelmovements,abdominaldiscomfort, stresslevel, sleeppattern, relief ofpainful conditions,menstrualpain,andmore free flow ofmenstrual blood.

Only 46 were senta questionnaireat the end.

Berman(2004,Sweden)47

RCT:Randomizationmethod: manuallottery; Control:comparisonacupuncture;Blinding: NR.

Age: mean 33.5 yr;Gender:F:M61:97;Referral: inmatesin two prisons withsubstance abusehistory; Durationof the condition:NR.

163 2 groups:1. NationalAssociationfor DetoxAcupuncture(NADA)Auricularacupuncture(specific);2. Helixauricularacupuncture(non-specific).

5x duringfirst wk,3x/wk for3 wkstotalof 14 sessionsin 4 wks, eachlasts 40 min.

NADA: b/lShenmen,sympathetic,KI, LR, LU;Helix: b/l 5points on thehelix, notavoiding theliver yangpoints.

Drug usequestionnaire,SCL-90, TCS.ATAS beforeand after eachtreatment. Urinedrug tests everyother day.Interviews beforeand after 4 wk.

Before andafter each4 wktreatments.

No majordifferences b/wgroups. Betterabstinence fromhelix, confidencein treatmentgrows with NADA.For sleep: 77%with better sleepin NADA; 50% withbetter sleep inhelix.

Randomizationresults werelost for 5 subjectsand therefore theywere excluded.Out of 158, 76completed the Rx.

Cohen(2003,USA)48

RCT:Randomizationmethod: priorideterminedassignment perparticipantnumber in sealedenvelopes;Control:comparisonacupuncture;Blinding: doubleblinded (subjectsand evaluators),blindingevaluation NR.

Age: NR; Gender:all females;Referral: post-menopausalwomen, off othertreatments for3 months;Duration of thecondition: 3months to 2 yr.

17 2 groups:experimentalacupuncture (EA)group (n8);comparisonacupuncture (CA)(n9).

Intervention:qw3 wks,then qow3(total of 6Rx),each treatment20e30 min. EA:needling ofacupoints relatedto treatment ofmenopausalsymptoms; CA:designed forgeneraltonification.

EA: BL15, BL23,BL32, GV20,HT7, PC6, SP6,LR3, SP9; CA:HT7 LR4, KI7,ear Shenmen,sympathetic,KI, LR, LU.

Daily diarymonthly for4 months, scores0e3 given tovarious symptomcategories, meanmonthly scoresamong subjectswere used forstatisticalanalysis.

Baseline,every month4(including3 wks post-intervention).

EA: significantYhotflush severity,but rebound atf/u; significantimprovements insleep and mood,lasting throughf/u; CA: Moodborderlineimproved duringRx. No change inhot flush severity orsleep during Rx butboth improvedduring f/u.

1 dropout afterbaseline. Baselinedata notcomparable b/wgroups. Nostatistical analysesb/w groups.


Acu

punctu

reforinsomnia

97

Table 6 (continued)

Author(year, area)


Jackson(2006,UK)49

n1 designcontrolled trials;control: withinsubject.

Age: 32e79 yr;Gender: F:M1:5;Referral: outptswith tinnitus;Duration of thecondition: 12months to over20 yr.

6 NA Individualizedacupuncture at6e13 points eachsession.Moxibustion andauricularacupuncture werealso applied. 5x/wk2wks (total of10 treatments).

Main: TE17,GB2; either KI3and BL23, orLR3. Otherpoints wereselectedaccording toothersymptoms.

Daily diaryto score 4tinnitus-related symptomsincluding qualityof sleep in 0e10scale. THI andMYMOP at 5 timespoints.

14 days pre-,at the start,at the end,14days post-,and 6 wkspost-Rx.Total of5 timepoints.

The combinedtreatmenteffects ofacupuncturesupported amore consistentand significantimprovement inthe reductionof waking hoursand improvedquality of sleep.The THI andMYMOP showeda trend ofimprovement.

A hierarchicalBayesian modelfor analysis ofn1 trials wasused.

Janssen(2005,Canada)50

Prospective caseseries.

Age: 30e49 yr;Gender: M>F;Referral:Canadian pooresturban populationwith high use ofdrugs;acupunctureoffered at 2communityagencies; Durationof the condition:NR.

39 NA Voluntarydrop-in up to5 days/wk;each session35e40 min.

b/l earpoints:sympathetic,shenmen,LR, KI, LU.

Weeklyquestionnaire onFridays.

Once a weekduring Rx.

Significantreduction inself-reportedfrequency ofsubstance use.Significantdecrease inintensity ofwithdrawals/s, includinginsomnia, shakes,stomach cramps,hallucinations,muddle-headedness,muscle aches,nausea, sweating,feeling suicidal,heartpalpitations.

*3months periodwith total 2755.visits; 39 subjectsfinished all 4 wksof Rx.

98W.Huangetal.

Schneider(2006,Germany)51

RCT:Randomizationmethod: blockrandomization;Control: shamcontrol; Blinding:double blinded(subjects andevaluator), noblinding processevaluationreported.

Age: mean for AC47.63 and SAC47.14; Gender:F:M34:9;Referral: Outpt GIclinic; Condition:Rome IIclassification forIBS; Duration ofthe condition:over 55% >10 yr.

43 2 groups:acupuncture(AC; n22); shamacupuncture(SAC; n21).

Intervention: 2x/wk for 5 wks(total 10 Rx). AC:with Deqisensation atacupoints, SAC:Streitbergerneedle at 2 cmaway fromacupoints.

LR3, ST36, SP6,CV12, ST21,ST25, HT7,GV20.

FDDQL (includingsleep eval),SF-36.

Pre-, post-treatment,3 monthsf/u.

Many areas ofFDDQLgot significantimprovements inboth groups, notincluding sleep.SF-36 improvedsignificantly onlyin pain in bothgroups. Therewas with nodifferenceb/w groups.

2 female subjectsdropout during thecourse of study.Poor sleep and lowcoping capacitypredict non-response toplacebo effects.

Shulman(2002,USA)52

Pilot study Age: mean 68 yr;Gender:F:M8:12;Referral: Outptswith diagnosis ofParkinsonsDisease stages IeIII, on stable meddose 1 month;Duration of thecondition: mean8.5 yr.

20 NA Rx:Combinationof body, scalp,and electro-acupuncture.1 h/session,2x/wk. First 7subjects received10 Rx; last 13 ptsreceived 16 Rx.

Body: LI4,GB34, ST36;KI3, KI7, SP6,SI3, TE5.(*main)Scalp: 9needles inchorea-tremblingcontrol area.Electro: NR.

Patientquestionnaires,SIP, UPDRS, H&Y,S&E, BAI, BDI,quantitativemotor tests,and adverseevents.

Before,within5 daysafter alltreatments.

The onlysignificantimprovementseen post-acupuncture issleep and rest.85% patientsreported alsosubjectiveimprovements inother s/s, e.g.,tremor,handwriting, pain,walking, slowness,anxiety,depression. Noadverse effects.

Subjectiveimprovements notverified byobjectiveassessments.


Acu

punctu

reforinsomnia

99

able 6 (continued)

uthoryear, area)


ang (2006,China)53

RCT:Randomizationmethod:according tothe admissiondate (odd-treatment vs.even-control);Control:medicationonly; Blinding:None.

Age: 21e68 yr;Gender:F:M23:22;Referral: inptdiagnosed withdepressionaccording toCCMD-3, withHDS > 18;Duration of thecondition: NR.

45 2 groups: 1.treatmentgroup:acupuncturewithmedication(n23); 2.control group:medicationonly (n22).

Acupuncture withQi conductingmaneuver:2e3 min peracupoints alongthe GV, plusadjunct bodypoints by TCM dx;Qd4 wks (28Rx);medications:individualizedSertraline 50e100 mg/day,Venlafaxine 75e100 mg/day, orRemeron 15e45 mg/day.

Main: GV24,GV20, GV14,GV11, GV9;Adjunct pointsvary to TCM dx.

HDS; PSQI Pre- andpost-treatments.

Both groupshad significantdecrease ofHDS scores, butonly thetreatment grouphad significantdecrease of PSQI.

Comparability ofmed use in the twogroups: NR. Articlealso reportedmore significantYHDS scores in thetreatment groupthan the controlgroup, but nodata.

ang (2007,Taiwan)54

Within subjectcrossover.

Age: over 65 yr;Gender:F:M7:13*;Referral: NHresidents 13 wks,with dementia andsevere agitation(CMAI 40);Duration of thecondition: 12months to over20 yr.

31* Within subjectcrossover: 1.Study: pretest1wk, acupressuretreatment 4 wks,post1 wk; 2.Washout: rest1 wk; 3. Control:pretest 1 wk,visiting andconversation 4wks, post 1 wk.

Acupressure:5 min warm-up(rubbing palms/fingers of bothhands), 2 minmassage eachacupoint (10 min)with average forceof 3.68e3.82 kg;2x/day for 5 days,rest 2 days, totalof 4 wks (40Rx).Control: daily visitand conversationfor 15 min/each.

GB20, GV20,HT7, PC6,SP6.

CMAI, andease of careinventory wereevaluated4 times duringthe study. Also,daily agitatedbehaviors wererecorded.

1 wk pre-test,1 wk post-test. 2 roundsduring thestudy, beforeand aftercrossover.

All aspects ofagitation behaviorwere significantlyimproved;although after6wks control,scores worsened,most trends ofimprovementlasted till the end.Patients were alsoobserved to fallasleep naturallywith acupressure(no specificmeasurements).

During the13wksdstudyperiod, there were11 dropouts: dueto hospitalizationor discharge * ofsubjects do notmatch.

ll abbreviations, except for those representing different study groups as indicated in the table, are listed in the Appendices.# of subjects do not match.

100W.Huangetal.T

A(

W

Y

A*

The reported number ranges from 1 to 60, with insomnia that may not be available using other

To the extent that TCM has long suggested that

Acupuncture for insomnia 101a median of 11 and a mean of 15 treatments,although the most optimal treatment durationremains an uncertain issue.

Insomnia diagnosisWhat is the association between insomnia diag-nosis and acupuncture efficacy?

Insomnia can be diagnosed according toWestern or TCM systems. In Western medicine,insomnia is divided into primary and comorbidinsomnia. Both in studies that specified primaryinsomnia20,25,32,34 and comorbid insomnia, e.g.,AIDS,35 anxiety,40 pregnancy,17 stroke,19 and ESRDpatients on HD,23,24 acupuncture treatments wereshown to be effective. In addition, Lees study33

illustrated that a positive response to acupuncturetreatments was not affected by multiple concur-rent medical problems.

In TCM, however, there are many insomniadiagnoses, according to the involvement ofdifferent organ systems in excessive or deficientforms. Lu34 reported that certain TCM syndromes(e.g., excess) were more easily treated withacupuncture than other types (e.g., deficiency).This finding is very interesting and is consistentwith the first authors (WH) clinical practiceexperience.

It remains to be seen whether research proto-cols employing Western insomnia diagnoses versusthose based on TCM differentials will lead to themost successful clinical trials and possibly eluci-date underlying mechanisms.

How safe is acupuncture in treatinginsomnia?

Studies that reported side effects of acupuncturehave reported local ecchymoses at needle inser-tion points,17 and skin irritation and mild pain atvaccaria seeds taping area.42 There have been noserious side effects reported to be associatedwith acupuncture treatments for insomnia. Thiscould be one of the unique features of acupunc-ture in comparison with other medical treat-ments, especially in selected populations such asthe elderly and patients with multiple medicalcomorbid conditions and taking multiplemedications.

What are possible underlying mechanisms ofacupuncture in treating insomnia?

Acupuncture offers great potential for enhancingour understanding of the pathophysiologic basis forheart is a main organ system controlling sleep,this opens up many avenues of research. Forexample, Lee33 demonstrated that modulation ofheart rate correlated with improvements ofinsomnia. Sleep also improved when stimulatingthe paraspinal bladder meridian in somestudies,25,45 while Teitelbaum62 observed a corre-lation between this meridian and the anatomicalANS efferent locations along the spine. ANSinvolvement in acupuncture treatment of insomniais also implicated by the use of auricular acu-points, which are thought to be able to regulateautonomic sympathetic/parasympathetic tone,63

and, as a consequence, produce beneficial effectson sleep. These findings warrant further investi-gational efforts in clinical trials, to both testacupunctures efficacy and to enhance our under-standing of pathophysiologic mechanisms contrib-uting to poor sleep.

Conclusion

The currently available studies have demonstratedthe safety and potential beneficial effects ofacupuncture in treating most forms of insomnia.However, the evidence is severely limited by studybias and significant heterogeneity of acupuncturetechniques and acupoint selections. Futureacupuncture research will require more vigorousstudy designs to evaluate not only the effects ofacupuncture in treating insomnia in comparison tosham acupuncture, but also to search for bettertreatment paradigms and to understand possibleunderlying mechanisms, all of which can elucidatewhether acupuncture can contribute to the clinicalcare of patients with insomnia.treatment modalities. For example, acupuncturetreatments that were targeted at other medical orpsychological conditions (see Table 6) also improvedsleep, indicatingpossiblecommonendocrinemarkersand/or neurotransmitter systems across theseconditions that can be regulated by acupuncture.Melatonin was suggested in one study40 as sucha factor.

Perhaps the most intriguing aspect of insomniathat could be elucidated by the use of acupuncturetreatment would be direct manipulation of theautonomic nervous system (ANS). ANS dysregula-tion of cardiac function may be particularly rele-vant for poor sleep56,57; individuals with insomniahave also been recognized to have higher heartrates than good sleepers58,59 and short sleepduration may be associated with hypertension.60,61

Practice points

1. Current evidence does not yet provideunequivocal supportof theuseof acupuncturein treating insomniaasmainmedicalmodality,although there has been some observed clin-ical effectiveness in certain patients.

2. Acupuncture is safe when used to treatinsomnia; auricular and body acupuncture ortheir variants,with an average 15 treatments,are the most commonly used treatmenttechniques.

Research agenda

1. More vigorously designed randomized clin-ical trials will be needed to demonstrate theeffectiveness of acupuncture in treatinginsomnia, with particular attention toinsomnia definition, sham control process,blinding, treatment paradigm, outcomemeasurements and follow-up periods.

Appendix II. Abbreviations in alphabet-ical order

# numberAHI Apnea/Hypopnea IndexAI Apnea IndexAIDS Acquired Immune Deficiency SyndromeATAS Acupuncture Treatment Assessment

Scale measuring worry, muscle tension,drug craving, physical well-being,and psychological well-being

b/l bilateralb/w betweenBAI Beck Anxiety InventoryBDI Beck Depression Inventorybid twice a dayc/o complain ofCCMD-3 China Classification of Mental Disorders

Third RevisionCGI Clinical Global ImpressionCMAI Cohen-Mansfield Agitation InventoryCSQI Current Sleep Quality IndexCT clinical trialdis disorder/disease(s)Dx diagnosisESRD end-stage renal diseaseeval evaluationf/u follow-upFDDQL Functional Digestive Diseases Quality

of Life QuestionnaireGI gastroenterology

102 W. Huang et al.Acknowledgment

2. Mechanistic evaluation of acupuncture intreating insomnia should also be pursued.Supported in part by the Southeast Center ofExcellence in Geriatric Medicine, Hartford Foun-dation Grant #97333-G.

Appendix I. Acupuncture nomenclatureused in this review

BL bladderCV conception vessel meridianGB gall bladderGV governing vessel meridianHT heartKI kidneyLI large IntestineLR liverLU lungPC pericardialSI small intestineSP spleenST stomachTE triple energizer (triple heater)

Note: when these are used alone, they represent acupoints(usually auricular); when these are used with a numberfollowing, they represent meridians, e.g., HT7 is the 7th pointon the Heart meridian.

h hour(s)H&Y Hoehn and YahrHA headache(s)HD HemodialysisHDS Hamilton Depression ScaleIBS Irritable Bowel SyndromeInpt InpatientISI Insomnia Severity Indexmed medication(s)min minute(s)MYMOP Measure Your Medical Outcome ProfileNA not applicableNH nursing homeNR not reportedOutpt Outpatient(s)PGS polysomnographypo take by mouthPSQI Pittsburgh Sleep Quality Indexpsych psychiatricPT physical therapyQd once a dayqhs every night before bedtimeQOD every other dayQoL quality of lifeqow once every other weekqw once a week/per weekRCT randomized clinical trialRx treatment

*12. Maciocia G. Foundations of Chinese Medicine: a compre-S&E Schwab and Englands/s symptomsSCL-90 Swedish research version of the

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