<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01726504</url>
  </required_header>
  <id_info>
    <org_study_id>2012BAI24B01</org_study_id>
    <nct_id>NCT01726504</nct_id>
  </id_info>
  <brief_title>The Efficacy and Safety Study of Electro-acupuncture for Severe Chronic Functional Constipation</brief_title>
  <official_title>The Efficacy and Safety Study of Electro-acupuncture for Severe Chronic Functional Constipation - a Multi-center, Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Guang'anmen Hospital of China Academy of Chinese Medical Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Ministry of Science and Technology of the People´s Republic of China</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Guang'anmen Hospital of China Academy of Chinese Medical Sciences</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The main purpose of this study is to evaluate efficacy of electro-acupuncture for severe&#xD;
      functional constipation compared with sham acupuncture, used as placebo; the secondary&#xD;
      purpose is to evaluate the safety and post-treatment effect of electro-acupuncture.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Chronic functional constipation is a common disease. To date there has not specific therapy&#xD;
      on chronic functional constipation. Systematic reviews indicate that acupuncture is probably&#xD;
      effective for the disease, but the evidence is limited. Recently, we have finished a&#xD;
      multi-center clinical trial of individualized deep electro-acupuncture (EA) for chronic&#xD;
      functional constipation (n=460, Registration ID: NCT00508482) which preliminarily showed EA&#xD;
      was effective.&#xD;
&#xD;
      This multi-center large-sample randomized controlled clinical trial of acupuncture for severe&#xD;
      functional constipation is designed to confirm the efficacy and safety of EA.&#xD;
&#xD;
      This project is conducted by Chinese experts, supported by the Chinese Government. The&#xD;
      research result is expected to provide high quality evidence of EA for chronic functional&#xD;
      constipation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">December 2014</completion_date>
  <primary_completion_date type="Actual">October 2014</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>the Change in Mean Weekly CSBMs During Weeks 1-8 Since Treatment</measure>
    <time_frame>Baseline and weeks 1-8</time_frame>
    <description>the change number in mean weekly CSBMs during weeks 1-8 since treatment compared with baseline.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>the Percentage of Participants With Three or More Weekly CSBMs</measure>
    <time_frame>1-20 weeks</time_frame>
    <description>the percentage of participants with three or more weekly CSBMs during weeks 1-8 and weeks 9-20</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Mean Weekly CSBMs During Weeks 9-20</measure>
    <time_frame>Baseline and weeks 9-20</time_frame>
    <description>The changed number in mean weekly average CSBMs during 9-20th weeks, compared with baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Weekly SBMs During Weeks 1-8</measure>
    <time_frame>Baseline and weeks 1-8</time_frame>
    <description>The changed number in mean of weekly average SBMs (spontaneous bowel movement) during 8-week treatment, compared with baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Scores for Stool Consistency and Straining During Weeks 1-8</measure>
    <time_frame>Baseline and weeks 1-8</time_frame>
    <description>average weekly stool consistency (Bristol Stool Scale) assessment of self-defecation during the 1-8weeks of treatment,compared with baseline. Bristol Stool Scale including 7-type, scored by 1 to 7 respectively.Type 1: Separate hard lumps, like nuts (hard to pass); Type 2: Sausage-shaped, but lumpy; Type 3: Like a sausage but with cracks on its surface; Type 4: Like a sausage or snake, smooth and soft; Type 5: Soft blobs with clear cut edges (passed easily); Type 6: Fluffy pieces with ragged edges, a mushy stool; Type 7: Watery, no solid pieces. Entirely liquid. Type 3, 4 are normal.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of Average Weekly Degree of Difficulty in Defecation From Baseline</measure>
    <time_frame>Baseline and weeks 1-8</time_frame>
    <description>The degree of straining during self-defecation: The severity of straining is graded using a 4-point ordinal scale.&#xD;
0 = not at all&#xD;
= more straining than not&#xD;
= a great deal&#xD;
= an extreme amount, need finger manipulation to defecate average weekly degree of difficulty in self-defecation during 1-8weeks,compared with baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Then Change Score of Health-related Quality of Life Via Patient-Assessment of Constipation Quality Of Life (PAC-QOL)</measure>
    <time_frame>baseline and the end of 8th week</time_frame>
    <description>Patient-Assessment of Constipation Quality Of Life(PAC-QOL) ranges are 28-140,and higher values represent a worse outcome.Subscales are summed to compute the total score. The changed score of PAC-QOL at week 8, compared with baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Adverse Events Related to Acupuncture</measure>
    <time_frame>1-8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean of Weekly Frequency of Rescue Medicine and Other Defecation Assistances Used</measure>
    <time_frame>1-20 weeks</time_frame>
    <description>Rescue medicine for constipation during the trial will be recorded. For rescue medicine, any participants experiencing no bowel movements for 3 or more consecutive days during the whole trial period were allowed to use a 110 ml glycerol anal enema or 40-60 ml sorbitol anal enema as a rescue medicine with documentation in the stool diary.Other If a patient used other medicine, it should be also recorded in the diary.Only the frequences of rescue medicine and other medicine for constipation will be recorded in diary by patient. Weekly frequencies were combined across Weeks 1-8 and 9-20 per participant by averaged across all measurements.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Number of Participants Using Rescue Medicine for Constipation</measure>
    <time_frame>1-20 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Weekly Frequency of Rescue Medicine and Other Defecation Assistances Used</measure>
    <time_frame>1-20 weeks</time_frame>
    <description>Rescue medicine for constipation during the trial will be recorded. For rescue medicine, any participants experiencing no bowel movements for 3 or more consecutive days during the whole trial period were allowed to use a 110 ml glycerol anal enema or 40-60 ml sorbitol anal enema as a rescue medicine with documentation in the stool diary.Other If a patient used other medicine, it should be also recorded in the diary.Only the frequences of rescue medicine and other medicine for constipation will be recorded in diary by patient. Weekly frequencies were combined across Weeks 1-8 and 9-20 per participant by averaged across all measurements.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">1075</enrollment>
  <condition>Constipation</condition>
  <arm_group>
    <arm_group_label>electro-acupuncture</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The electric stimulator is applied to bilateral ST25andSP14 with dilatational wave10/50 Hz and electric current0.1-1.0mA.They are given acupuncture with 0.3×50mm or 0.35×75mm needles by inserting30-70mm and twirling lifting andthrusting 3 times.Dosage:The needle arrives the abdominal muscle layer(patients feel painful and acupuncturists feel touching hard).&#xD;
Bilateral ST37 are given conventional acupuncture with 0.30mm×40mm needles by inserting 25-30mm and twirling lifting and thrusting for 3.Dosage:Local sour and heavy feeling is the appropriate dose.&#xD;
Every session lasts for 30min/day.The participants are treated continuously for 8 weeks.During 8-week treatment the first 2 weeks,5 sessions per week,and 3 sessions per week in the rest 6 weeks,28 sessions for each patients in total.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>sham electro-acupuncture</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>The electric stimulator is applied to bilateral sham ST25 and sham SP14 with dilatational wave, 10/50 Hz and electric current 0.5mA. The mental wire has been cut off with a same outlook as the treatment group. The electric stimulator is looked normal but with no current output. The needle is inserted by 3mm-5mm (the needle can be vertically fixed on the skin).&#xD;
Bilateral ST37 are given acupuncture with 3mm-5mm (the needle can be vertically fixed on the skin).&#xD;
Length of Treatment and the treatment sessions are the same as treatment group.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>electro-acupuncture</intervention_name>
    <description>Procedure: electro-acupuncture; Points:Tianshu (ST25) Fujie(SP14), Shangjuxu (ST37).Pierced the skin, needles are inserted 30to70mm into bilateral ST25 and SP14 vertically until piercing the abdominal muscle layer.Electric stimulator is applied to bilateral ST25 and SP14 with dilatational wave, 10/50 Hz and electric current 0.1-1.0mA. The participant's abdominal muscle twitching mildly is the appropriate dose. Bilateral ST37 are inserted 25-30mm and then twirling lifting and thrusting for 3 times.Local sour and heavy feeling is appropriate dose. Steady small twirling lifting and thrusting 3 times in all. 30 min/per day/per session.During the 8 weeks treatment, the first 2 weeks,5 sessions per week, and 3 sessions per week in the rest 6 weeks,28 sessions for each patients in total.</description>
    <arm_group_label>electro-acupuncture</arm_group_label>
    <other_name>SDZ-V electro-acupuncture apparatus (Huatuo, made in China)</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>sham electro-acupuncture</intervention_name>
    <description>Procedure:sham electro-acupuncture;Points:Sham Tianshu(ST25),sham Fujie(SP14),sham Shangjuxu (ST37).Sham points location:20mm away from ST25,middle of Spleen and Stomach Channel;30mm from SP14,middle of Spleen and Stomach Channel; one point beside ST37,middle of Stomach and Gallbladder Channel; Performance:The needle is inserted with needle of 0.30×25mm by 3-5mm. No twirling lifting and thrusting. The electric stimulator is applied to bilateral sham ST25 and sham SP14 with dilatational wave,10/50 Hz and electric current 0.5mA.The mental wire has been cut off with a same outlook as the treatment group.The electric stimulator is looked normal but with no current output. Length of Treatment and the treatment sessions are the same as treatment group.</description>
    <arm_group_label>sham electro-acupuncture</arm_group_label>
    <other_name>Sham SDZ-V electro-acupuncture apparatus (Huatuo, China)</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  meeting the diagnosis of Rome III criteria for chronic functional constipation;&#xD;
&#xD;
          -  severe chronic constipation: two or fewer spontaneous complete bowel movements per&#xD;
             week for more than 3 months;&#xD;
&#xD;
          -  18-75 years old;&#xD;
&#xD;
          -  no use of medicine for constipation during the two weeks before enrollment (except&#xD;
             rescue medication);&#xD;
&#xD;
          -  no acupuncture treatment for constipation in recent 3 months;&#xD;
&#xD;
          -  never joined any other trial in process in 3 months;&#xD;
&#xD;
          -  volunteered to join this research and signed the informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Irritable bowel syndrome (IBS) and constipation caused by endocrine, metabolic,&#xD;
             nervous or postoperative diseases or drugs;&#xD;
&#xD;
          -  constipation accompanied by serious cardiovascular, hepatic, renal, or psychiatric&#xD;
             disease, cognitive dysfunction or aphasia, or severe dystrophy affecting the&#xD;
             cooperation for examination or treatment;&#xD;
&#xD;
          -  pregnant women or women in lactation period&#xD;
&#xD;
          -  constipation accompanied by abdominal aneurysm, hepatosplenomegaly, etcetera;&#xD;
&#xD;
          -  bleeding disorders, or regular anticoagulant drug users, such as warfarin and heparin,&#xD;
             etcetera;&#xD;
&#xD;
          -  cardiac pacemaker carrier.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Baoyan Liu, Master</last_name>
    <role>Principal Investigator</role>
    <affiliation>Vice President of China Academy of Chinese Medical Sciences</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Guang'anmen Hospital of China Academy of Chinese Medical Sciences</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100700</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>January 2016</verification_date>
  <study_first_submitted>October 30, 2012</study_first_submitted>
  <study_first_submitted_qc>November 14, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 15, 2012</study_first_posted>
  <results_first_submitted>September 3, 2015</results_first_submitted>
  <results_first_submitted_qc>October 21, 2015</results_first_submitted_qc>
  <results_first_posted type="Estimate">November 23, 2015</results_first_posted>
  <last_update_submitted>January 21, 2016</last_update_submitted>
  <last_update_submitted_qc>January 21, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 22, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Guang'anmen Hospital of China Academy of Chinese Medical Sciences</investigator_affiliation>
    <investigator_full_name>Liu Baoyan</investigator_full_name>
    <investigator_title>Vice President of China Academy of Chinese Medical Sciences</investigator_title>
  </responsible_party>
  <keyword>chronic functional constipation</keyword>
  <keyword>electro-acupuncture</keyword>
  <keyword>multi-center randomized controlled trial</keyword>
  <keyword>efficacy</keyword>
  <keyword>safety</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Constipation</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Electro-acupuncture</title>
          <description>The acupuncture points are ST25, SP14,ST37. After sterilizing the skin, filiform needles are inserted 3 to 8 cm into bilateral ST25 and SP14 vertically and slowly without any manipulation until arrive the abdominal muscle layer(patients feel painful and acupuncturists feel touching hard). An electric stimulator (SDZ-V EA apparatus; Huatuo, China) is applied to bilateral ST25 and SP14 with a dilatational wave of 10/50 Hz and electric current between 0.1 and 1.0 mA with abdominal muscle twitching mildly indicating the appropriate dose.&#xD;
The bilateral ST37 is inserted 3cm - twirling, lifting and thrusting three times. A local sour and heavy feeling indicates the appropriate dose.&#xD;
Every session lasts for 30min/day. The participants are treated continuously for 8 weeks. During 8-week treatment the first 2 weeks,5 sessions per week, and 3 sessions per week in the rest 6 weeks,28 sessions for each patients in total.</description>
        </group>
        <group group_id="P2">
          <title>Sham Electro-acupuncture</title>
          <description>The acupuncture points are sham ST25, SP14, ST37. Sham location points are: about 2cm away from ST25,in the middle of the spleen and stomach channel; about 3 cm from SP14, in the middle of the spleen and stomach channel; one point beside ST37, in the middle of the stomach and gallbladder channel. The needle is inserted after sterilizing the skin by 1 to 1.5 cm, until the needle can be vertically fixed on the skin. No twirling lifting and thrusting manipulation is used. The sham electric stimulator (sham SDZ-V EA apparatus; Huatuo) is applied to the bilateral sham ST25 and sham SP14 with a dilatational wave of 10/50 Hz and electric current of 0.5 mA. The metal wire has been cut off inside to give the appearance of the real electric stimulator, with no current output. Length of treatment and the treatment sessions are the same as the treatment group sessions are the same as the treatment group.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="536"/>
                <participants group_id="P2" count="539"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="524"/>
                <participants group_id="P2" count="511"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="12"/>
                <participants group_id="P2" count="28"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Electro-acupuncture</title>
          <description>The acupuncture points are ST25, SP14,ST37. After sterilizing the skin, filiform needles are inserted 3 to 8 cm into bilateral ST25 and SP14 vertically and slowly without any manipulation until arrive the abdominal muscle layer(patients feel painful and acupuncturists feel touching hard). An electric stimulator (SDZ-V EA apparatus; Huatuo, China) is applied to bilateral ST25 and SP14 with a dilatational wave of 10/50 Hz and electric current between 0.1 and 1.0 mA with abdominal muscle twitching mildly indicating the appropriate dose.&#xD;
The bilateral ST37 is inserted 3cm - twirling, lifting and thrusting three times. A local sour and heavy feeling indicates the appropriate dose.&#xD;
Every session lasts for 30min/day. The participants are treated continuously for 8 weeks. During 8-week treatment the first 2 weeks,5 sessions per week, and 3 sessions per week in the rest 6 weeks,28 sessions for each patients in total.</description>
        </group>
        <group group_id="B2">
          <title>Sham Electro-acupuncture</title>
          <description>The acupuncture points are sham ST25, SP14, ST37. Sham location points are: about 2cm away from ST25,in the middle of the spleen and stomach channel; about 3 cm from SP14, in the middle of the spleen and stomach channel; one point beside ST37, in the middle of the stomach and gallbladder channel. The needle is inserted after sterilizing the skin by 1 to 1.5 cm, until the needle can be vertically fixed on the skin. No twirling lifting and thrusting manipulation is used. The sham electric stimulator (sham SDZ-V EA apparatus; Huatuo) is applied to the bilateral sham ST25 and sham SP14 with a dilatational wave of 10/50 Hz and electric current of 0.5 mA. The metal wire has been cut off inside to give the appearance of the real electric stimulator, with no current output. Length of treatment and the treatment sessions are the same as the treatment group sessions are the same as the treatment group.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="536"/>
            <count group_id="B2" value="539"/>
            <count group_id="B3" value="1075"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="447"/>
                    <measurement group_id="B2" value="457"/>
                    <measurement group_id="B3" value="904"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="89"/>
                    <measurement group_id="B2" value="82"/>
                    <measurement group_id="B3" value="171"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="415"/>
                    <measurement group_id="B2" value="407"/>
                    <measurement group_id="B3" value="822"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="121"/>
                    <measurement group_id="B2" value="132"/>
                    <measurement group_id="B3" value="253"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Han</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="519"/>
                    <measurement group_id="B2" value="526"/>
                    <measurement group_id="B3" value="1045"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Man</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hui</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Zhuang</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Miao</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Wei</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>other</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Body-mass index</title>
          <description>Body-mass index was measured by research assistants.Data were tested using Student's t test.</description>
          <units>kg/m^2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="22.32" spread="3.04"/>
                    <measurement group_id="B2" value="22.75" spread="3.00"/>
                    <measurement group_id="B3" value="22.54" spread="3.03"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Constipation duration (mon)</title>
          <description>Constipation duration was self-reported by participants.Data were tested using Student's t test.</description>
          <units>month</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="130.81" spread="122.61"/>
                    <measurement group_id="B2" value="132.71" spread="127.00"/>
                    <measurement group_id="B3" value="131.76" spread="124.78"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Coexisting illness</title>
          <description>Coexisting illnesses was self-reported by participants.Data were tested using chi-square test.</description>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Diabetes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hypertension</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="41"/>
                    <measurement group_id="B2" value="39"/>
                    <measurement group_id="B3" value="80"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Digestive system disease</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="16"/>
                    <measurement group_id="B3" value="27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Others</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="78"/>
                    <measurement group_id="B2" value="71"/>
                    <measurement group_id="B3" value="149"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>None</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="395"/>
                    <measurement group_id="B2" value="403"/>
                    <measurement group_id="B3" value="798"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Use of Other Measures by Participants</title>
          <description>Use of Other Measures by Participants:Data were tested using chi-square test.</description>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Rescue medicine</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="170"/>
                    <measurement group_id="B2" value="147"/>
                    <measurement group_id="B3" value="317"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Others</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                    <measurement group_id="B2" value="19"/>
                    <measurement group_id="B3" value="36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>None</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="349"/>
                    <measurement group_id="B2" value="373"/>
                    <measurement group_id="B3" value="722"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>average number of times other measures were used</title>
          <description>Average number of times other measures were used self-reported by participants.Data were tested using Student's t test.</description>
          <units>number of times per week</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <title>Rescue medicine</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0.66" spread="1.47"/>
                    <measurement group_id="B2" value="0.62" spread="1.91"/>
                    <measurement group_id="B3" value="0.64" spread="1.71"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Others</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0.08" spread="0.58"/>
                    <measurement group_id="B2" value="0.06" spread="0.43"/>
                    <measurement group_id="B3" value="0.07" spread="0.51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Complete Spontaneous Bowel Movements (CSBMs) Per Week</title>
          <description>Number of CSBMs/week during the 2-week screening period was calculated from participants' diaries by summing weekly CSBMs or SBMs then dividing by two.Data were tested using Student's t test.</description>
          <units>number of times</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0.39" spread="0.62"/>
                    <measurement group_id="B2" value="0.42" spread="0.62"/>
                    <measurement group_id="B3" value="0.41" spread="0.62"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Spontaneous Bowel Movements (CSBMs) Per Week</title>
          <description>SBMs/week during the 2-week screening period was calculated from participants' diaries by summing weekly CSBMs or SBMs then dividing by two.</description>
          <units>number of times</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1.90" spread="1.34"/>
                    <measurement group_id="B2" value="2.02" spread="1.45"/>
                    <measurement group_id="B3" value="1.96" spread="1.40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Score of Patient Assessment of Constipation Quality of Life(PAC-QOL)</title>
          <description>The PAC-QOL was administered by research assistants at the baseline visit and was reported by participants.Data were tested using Student's t test.PAC-QOL scale ranges are 28-140,and higher values represent a worse outcome.Subscales are summed to compute the total score.</description>
          <units>scores on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="77.06" spread="19.27"/>
                    <measurement group_id="B2" value="75.06" spread="19.26"/>
                    <measurement group_id="B3" value="76.06" spread="19.28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>the Change in Mean Weekly CSBMs During Weeks 1-8 Since Treatment</title>
        <description>the change number in mean weekly CSBMs during weeks 1-8 since treatment compared with baseline.</description>
        <time_frame>Baseline and weeks 1-8</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Electro-acupuncture</title>
            <description>Electroacupuncture (EA) group consisted of 28 sessions of 30 minutes' duration, each administered over a period of 8 weeks. Huatuo disposable needles and EA apparatus, type SDZ-V(Suzhou Medical Appliance, China) were used. Participants in the EA group received EA at bilateral acupoints of ST25, SP14,ST37. With participant supine, 0.30 mm×50 mm or 0.35mm×75mm needles were inserted into ST25 and SP14 slowly and vertically, without manipulation, for approximately 30 to 70mm until they pierced the muscle layer of the abdominal wall. EA apparatus were attached transversely to bilateral ST25 and SP14, lasted for 30 minutes with a dilatational wave of 10/50Hz and current intensity of 0.1 to 1 mA depending on participant's comfort level. 0.30mm × 40mm needles were inserted into ST37 vertically for about 30mm and three small, equal manipulations of twirling, lifting, and thrusting were performed to reach acupuncture de qi.</description>
          </group>
          <group group_id="O2">
            <title>Sham Electro-acupuncture</title>
            <description>Sham Electroacupuncture (SA) group consisted of 28 sessions of 30 minutes' duration, each administered over a period of 8 weeks (five sessions in each of the first 2 weeks, followed by 3 sessions per week in the remaining 6 weeks). Huatuo disposable needles and EA apparatus, type SDZ-V (Suzhou Medical Appliance, China) were used. Participants in SA group received needling at bilateral non-acupoints of sham ST25, sham SP14, sham ST37. Specifically, 0.30 mm × 25 mm needles were used to penetrate the skin vertically at approximately 3 to 5 mm without any manipulation. Similar to EA group, paired alligator clips from the specially constructed EA apparatus were attached to the needle holders. When switched on, the EA apparatus in the SA group had the same working power indicator and sound but no actual current output. Additionally, 0.30 mm × 25 mm needles were inserted into sham ST37 vertically at about 3 - 5 mm without manipulation.</description>
          </group>
        </group_list>
        <measure>
          <title>the Change in Mean Weekly CSBMs During Weeks 1-8 Since Treatment</title>
          <description>the change number in mean weekly CSBMs during weeks 1-8 since treatment compared with baseline.</description>
          <units>number of times</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="536"/>
                <count group_id="O2" value="539"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.72" spread="0.12"/>
                    <measurement group_id="O2" value="0.82" spread="0.13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>During the 8-week treatment period, the adjusted change from baseline in mean weekly CSBMs was 1.72 ± 0.12 (95% CI, 1.48 to 1.96) in the EA group and 0.82 ± 0.13 (95% CI, 0.58 to 1.07, P&lt;0.001) times more than that in the SA group.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Mixed Models Analysis</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>the Percentage of Participants With Three or More Weekly CSBMs</title>
        <description>the percentage of participants with three or more weekly CSBMs during weeks 1-8 and weeks 9-20</description>
        <time_frame>1-20 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Electro-acupuncture</title>
            <description>Electroacupuncture (EA) group consisted of 28 sessions of 30 minutes' duration, each administered over a period of 8 weeks. Huatuo disposable needles and EA apparatus, type SDZ-V(Suzhou Medical Appliance, China) were used. Participants in the EA group received EA at bilateral acupoints of ST25, SP14,ST37. With participant supine, 0.30 mm×50 mm or 0.35mm×75mm needles were inserted into ST25 and SP14 slowly and vertically, without manipulation, for approximately 30 to 70mm until they pierced the muscle layer of the abdominal wall. EA apparatus were attached transversely to bilateral ST25 and SP14, lasted for 30 minutes with a dilatational wave of 10/50Hz and current intensity of 0.1 to 1 mA depending on participant's comfort level. 0.30mm × 40mm needles were inserted into ST37 vertically for about 30mm and three small, equal manipulations of twirling, lifting, and thrusting were performed to reach acupuncture de qi.</description>
          </group>
          <group group_id="O2">
            <title>Sham Electro-acupuncture</title>
            <description>Sham Electroacupuncture (SA) group consisted of 28 sessions of 30 minutes' duration, each administered over a period of 8 weeks (five sessions in each of the first 2 weeks, followed by 3 sessions per week in the remaining 6 weeks). Huatuo disposable needles and EA apparatus, type SDZ-V (Suzhou Medical Appliance, China) were used. Participants in SA group received needling at bilateral non-acupoints of sham ST25, sham SP14, sham ST37. Specifically, 0.30 mm × 25 mm needles were used to penetrate the skin vertically at approximately 3 to 5 mm without any manipulation. Similar to EA group, paired alligator clips from the specially constructed EA apparatus were attached to the needle holders. When switched on, the EA apparatus in the SA group had the same working power indicator and sound but no actual current output. Additionally, 0.30 mm × 25 mm needles were inserted into sham ST37 vertically at about 3 - 5 mm without manipulation.</description>
          </group>
        </group_list>
        <measure>
          <title>the Percentage of Participants With Three or More Weekly CSBMs</title>
          <description>the percentage of participants with three or more weekly CSBMs during weeks 1-8 and weeks 9-20</description>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="536"/>
                <count group_id="O2" value="539"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 1-8</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31.34"/>
                    <measurement group_id="O2" value="12.06"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 9-20</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="37.69"/>
                    <measurement group_id="O2" value="14.10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Changes in Mean Weekly CSBMs During Weeks 9-20</title>
        <description>The changed number in mean weekly average CSBMs during 9-20th weeks, compared with baseline.</description>
        <time_frame>Baseline and weeks 9-20</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Electro-acupuncture</title>
            <description>Electroacupuncture (EA) group consisted of 28 sessions of 30 minutes' duration, each administered over a period of 8 weeks. Huatuo disposable needles and EA apparatus, type SDZ-V(Suzhou Medical Appliance, China) were used. Participants in the EA group received EA at bilateral acupoints of ST25, SP14,ST37. With participant supine, 0.30 mm×50 mm or 0.35mm×75mm needles were inserted into ST25 and SP14 slowly and vertically, without manipulation, for approximately 30 to 70mm until they pierced the muscle layer of the abdominal wall. EA apparatus were attached transversely to bilateral ST25 and SP14, lasted for 30 minutes with a dilatational wave of 10/50Hz and current intensity of 0.1 to 1 mA depending on participant's comfort level. 0.30mm × 40mm needles were inserted into ST37 vertically for about 30mm and three small, equal manipulations of twirling, lifting, and thrusting were performed to reach acupuncture de qi.</description>
          </group>
          <group group_id="O2">
            <title>Sham Electro-acupuncture</title>
            <description>Sham Electroacupuncture (SA) group consisted of 28 sessions of 30 minutes' duration, each administered over a period of 8 weeks (five sessions in each of the first 2 weeks, followed by 3 sessions per week in the remaining 6 weeks). Huatuo disposable needles and EA apparatus, type SDZ-V (Suzhou Medical Appliance, China) were used. Participants in SA group received needling at bilateral non-acupoints of sham ST25, sham SP14, sham ST37. Specifically, 0.30 mm × 25 mm needles were used to penetrate the skin vertically at approximately 3 to 5 mm without any manipulation. Similar to EA group, paired alligator clips from the specially constructed EA apparatus were attached to the needle holders. When switched on, the EA apparatus in the SA group had the same working power indicator and sound but no actual current output. Additionally, 0.30 mm × 25 mm needles were inserted into sham ST37 vertically at about 3 - 5 mm without manipulation.</description>
          </group>
        </group_list>
        <measure>
          <title>Changes in Mean Weekly CSBMs During Weeks 9-20</title>
          <description>The changed number in mean weekly average CSBMs during 9-20th weeks, compared with baseline.</description>
          <units>number of times</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="536"/>
                <count group_id="O2" value="539"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.93" spread="0.14"/>
                    <measurement group_id="O2" value="0.82" spread="0.14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Weekly SBMs During Weeks 1-8</title>
        <description>The changed number in mean of weekly average SBMs (spontaneous bowel movement) during 8-week treatment, compared with baseline.</description>
        <time_frame>Baseline and weeks 1-8</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Electro-acupuncture</title>
            <description>Electroacupuncture (EA) group consisted of 28 sessions of 30 minutes' duration, each administered over a period of 8 weeks. Huatuo disposable needles and EA apparatus, type SDZ-V(Suzhou Medical Appliance, China) were used. Participants in the EA group received EA at bilateral acupoints of ST25, SP14,ST37. With participant supine, 0.30 mm×50 mm or 0.35mm×75mm needles were inserted into ST25 and SP14 slowly and vertically, without manipulation, for approximately 30 to 70mm until they pierced the muscle layer of the abdominal wall. EA apparatus were attached transversely to bilateral ST25 and SP14, lasted for 30 minutes with a dilatational wave of 10/50Hz and current intensity of 0.1 to 1 mA depending on participant's comfort level. 0.30mm × 40mm needles were inserted into ST37 vertically for about 30mm and three small, equal manipulations of twirling, lifting, and thrusting were performed to reach acupuncture de qi.</description>
          </group>
          <group group_id="O2">
            <title>Sham Electro-acupuncture</title>
            <description>Sham Electroacupuncture (SA) group consisted of 28 sessions of 30 minutes' duration, each administered over a period of 8 weeks (five sessions in each of the first 2 weeks, followed by 3 sessions per week in the remaining 6 weeks). Huatuo disposable needles and EA apparatus, type SDZ-V (Suzhou Medical Appliance, China) were used. Participants in SA group received needling at bilateral non-acupoints of sham ST25, sham SP14, sham ST37. Specifically, 0.30 mm × 25 mm needles were used to penetrate the skin vertically at approximately 3 to 5 mm without any manipulation. Similar to EA group, paired alligator clips from the specially constructed EA apparatus were attached to the needle holders. When switched on, the EA apparatus in the SA group had the same working power indicator and sound but no actual current output. Additionally, 0.30 mm × 25 mm needles were inserted into sham ST37 vertically at about 3 - 5 mm without manipulation.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Weekly SBMs During Weeks 1-8</title>
          <description>The changed number in mean of weekly average SBMs (spontaneous bowel movement) during 8-week treatment, compared with baseline.</description>
          <units>number of times</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="536"/>
                <count group_id="O2" value="539"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.30" spread="0.10"/>
                    <measurement group_id="O2" value="1.28" spread="0.10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Scores for Stool Consistency and Straining During Weeks 1-8</title>
        <description>average weekly stool consistency (Bristol Stool Scale) assessment of self-defecation during the 1-8weeks of treatment,compared with baseline. Bristol Stool Scale including 7-type, scored by 1 to 7 respectively.Type 1: Separate hard lumps, like nuts (hard to pass); Type 2: Sausage-shaped, but lumpy; Type 3: Like a sausage but with cracks on its surface; Type 4: Like a sausage or snake, smooth and soft; Type 5: Soft blobs with clear cut edges (passed easily); Type 6: Fluffy pieces with ragged edges, a mushy stool; Type 7: Watery, no solid pieces. Entirely liquid. Type 3, 4 are normal.</description>
        <time_frame>Baseline and weeks 1-8</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Electro-acupuncture</title>
            <description>Electroacupuncture (EA) group consisted of 28 sessions of 30 minutes' duration, each administered over a period of 8 weeks. Huatuo disposable needles and EA apparatus, type SDZ-V(Suzhou Medical Appliance, China) were used. Participants in the EA group received EA at bilateral acupoints of ST25, SP14,ST37. With participant supine, 0.30 mm×50 mm or 0.35mm×75mm needles were inserted into ST25 and SP14 slowly and vertically, without manipulation, for approximately 30 to 70mm until they pierced the muscle layer of the abdominal wall. EA apparatus were attached transversely to bilateral ST25 and SP14, lasted for 30 minutes with a dilatational wave of 10/50Hz and current intensity of 0.1 to 1 mA depending on participant's comfort level. 0.30mm × 40mm needles were inserted into ST37 vertically for about 30mm and three small, equal manipulations of twirling, lifting, and thrusting were performed to reach acupuncture de qi.</description>
          </group>
          <group group_id="O2">
            <title>Sham Electro-acupuncture</title>
            <description>Sham Electroacupuncture (SA) group consisted of 28 sessions of 30 minutes' duration, each administered over a period of 8 weeks (five sessions in each of the first 2 weeks, followed by 3 sessions per week in the remaining 6 weeks). Huatuo disposable needles and EA apparatus, type SDZ-V (Suzhou Medical Appliance, China) were used. Participants in SA group received needling at bilateral non-acupoints of sham ST25, sham SP14, sham ST37. Specifically, 0.30 mm × 25 mm needles were used to penetrate the skin vertically at approximately 3 to 5 mm without any manipulation. Similar to EA group, paired alligator clips from the specially constructed EA apparatus were attached to the needle holders. When switched on, the EA apparatus in the SA group had the same working power indicator and sound but no actual current output. Additionally, 0.30 mm × 25 mm needles were inserted into sham ST37 vertically at about 3 - 5 mm without manipulation.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Scores for Stool Consistency and Straining During Weeks 1-8</title>
          <description>average weekly stool consistency (Bristol Stool Scale) assessment of self-defecation during the 1-8weeks of treatment,compared with baseline. Bristol Stool Scale including 7-type, scored by 1 to 7 respectively.Type 1: Separate hard lumps, like nuts (hard to pass); Type 2: Sausage-shaped, but lumpy; Type 3: Like a sausage but with cracks on its surface; Type 4: Like a sausage or snake, smooth and soft; Type 5: Soft blobs with clear cut edges (passed easily); Type 6: Fluffy pieces with ragged edges, a mushy stool; Type 7: Watery, no solid pieces. Entirely liquid. Type 3, 4 are normal.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="536"/>
                <count group_id="O2" value="539"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.87" spread="0.05"/>
                    <measurement group_id="O2" value="0.62" spread="0.04"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change of Average Weekly Degree of Difficulty in Defecation From Baseline</title>
        <description>The degree of straining during self-defecation: The severity of straining is graded using a 4-point ordinal scale.&#xD;
0 = not at all&#xD;
= more straining than not&#xD;
= a great deal&#xD;
= an extreme amount, need finger manipulation to defecate average weekly degree of difficulty in self-defecation during 1-8weeks,compared with baseline</description>
        <time_frame>Baseline and weeks 1-8</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Electro-acupuncture</title>
            <description>Electroacupuncture (EA) group consisted of 28 sessions of 30 minutes' duration, each administered over a period of 8 weeks. Huatuo disposable needles and EA apparatus, type SDZ-V(Suzhou Medical Appliance, China) were used. Participants in the EA group received EA at bilateral acupoints of ST25, SP14,ST37. With participant supine, 0.30 mm×50 mm or 0.35mm×75mm needles were inserted into ST25 and SP14 slowly and vertically, without manipulation, for approximately 30 to 70mm until they pierced the muscle layer of the abdominal wall. EA apparatus were attached transversely to bilateral ST25 and SP14, lasted for 30 minutes with a dilatational wave of 10/50Hz and current intensity of 0.1 to 1 mA depending on participant's comfort level. 0.30mm × 40mm needles were inserted into ST37 vertically for about 30mm and three small, equal manipulations of twirling, lifting, and thrusting were performed to reach acupuncture de qi.</description>
          </group>
          <group group_id="O2">
            <title>Sham Electro-acupuncture</title>
            <description>Sham Electroacupuncture (SA) group consisted of 28 sessions of 30 minutes' duration, each administered over a period of 8 weeks (five sessions in each of the first 2 weeks, followed by 3 sessions per week in the remaining 6 weeks). Huatuo disposable needles and EA apparatus, type SDZ-V (Suzhou Medical Appliance, China) were used. Participants in SA group received needling at bilateral non-acupoints of sham ST25, sham SP14, sham ST37. Specifically, 0.30 mm × 25 mm needles were used to penetrate the skin vertically at approximately 3 to 5 mm without any manipulation. Similar to EA group, paired alligator clips from the specially constructed EA apparatus were attached to the needle holders. When switched on, the EA apparatus in the SA group had the same working power indicator and sound but no actual current output. Additionally, 0.30 mm × 25 mm needles were inserted into sham ST37 vertically at about 3 - 5 mm without manipulation.</description>
          </group>
        </group_list>
        <measure>
          <title>Change of Average Weekly Degree of Difficulty in Defecation From Baseline</title>
          <description>The degree of straining during self-defecation: The severity of straining is graded using a 4-point ordinal scale.&#xD;
0 = not at all&#xD;
= more straining than not&#xD;
= a great deal&#xD;
= an extreme amount, need finger manipulation to defecate average weekly degree of difficulty in self-defecation during 1-8weeks,compared with baseline</description>
          <units>scores on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="536"/>
                <count group_id="O2" value="539"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.74" spread="0.03"/>
                    <measurement group_id="O2" value="-0.52" spread="0.03"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Then Change Score of Health-related Quality of Life Via Patient-Assessment of Constipation Quality Of Life (PAC-QOL)</title>
        <description>Patient-Assessment of Constipation Quality Of Life(PAC-QOL) ranges are 28-140,and higher values represent a worse outcome.Subscales are summed to compute the total score. The changed score of PAC-QOL at week 8, compared with baseline.</description>
        <time_frame>baseline and the end of 8th week</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Electro-acupuncture</title>
            <description>Electroacupuncture (EA) group consisted of 28 sessions of 30 minutes' duration, each administered over a period of 8 weeks. Huatuo disposable needles and EA apparatus, type SDZ-V(Suzhou Medical Appliance, China) were used. Participants in the EA group received EA at bilateral acupoints of ST25, SP14,ST37. With participant supine, 0.30 mm×50 mm or 0.35mm×75mm needles were inserted into ST25 and SP14 slowly and vertically, without manipulation, for approximately 30 to 70mm until they pierced the muscle layer of the abdominal wall. EA apparatus were attached transversely to bilateral ST25 and SP14, lasted for 30 minutes with a dilatational wave of 10/50Hz and current intensity of 0.1 to 1 mA depending on participant's comfort level. 0.30mm × 40mm needles were inserted into ST37 vertically for about 30mm and three small, equal manipulations of twirling, lifting, and thrusting were performed to reach acupuncture de qi.</description>
          </group>
          <group group_id="O2">
            <title>Sham Electro-acupuncture</title>
            <description>Sham Electroacupuncture (SA) group consisted of 28 sessions of 30 minutes' duration, each administered over a period of 8 weeks (five sessions in each of the first 2 weeks, followed by 3 sessions per week in the remaining 6 weeks). Huatuo disposable needles and EA apparatus, type SDZ-V (Suzhou Medical Appliance, China) were used. Participants in SA group received needling at bilateral non-acupoints of sham ST25, sham SP14, sham ST37. Specifically, 0.30 mm × 25 mm needles were used to penetrate the skin vertically at approximately 3 to 5 mm without any manipulation. Similar to EA group, paired alligator clips from the specially constructed EA apparatus were attached to the needle holders. When switched on, the EA apparatus in the SA group had the same working power indicator and sound but no actual current output. Additionally, 0.30 mm × 25 mm needles were inserted into sham ST37 vertically at about 3 - 5 mm without manipulation.</description>
          </group>
        </group_list>
        <measure>
          <title>Then Change Score of Health-related Quality of Life Via Patient-Assessment of Constipation Quality Of Life (PAC-QOL)</title>
          <description>Patient-Assessment of Constipation Quality Of Life(PAC-QOL) ranges are 28-140,and higher values represent a worse outcome.Subscales are summed to compute the total score. The changed score of PAC-QOL at week 8, compared with baseline.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="536"/>
                <count group_id="O2" value="539"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-25.65" spread="2.39"/>
                    <measurement group_id="O2" value="-18.21" spread="2.39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Adverse Events Related to Acupuncture</title>
        <time_frame>1-8 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Electro-acupuncture</title>
            <description>Electroacupuncture (EA) group consisted of 28 sessions of 30 minutes' duration, each administered over a period of 8 weeks. Huatuo disposable needles and EA apparatus, type SDZ-V(Suzhou Medical Appliance, China) were used. Participants in the EA group received EA at bilateral acupoints of ST25, SP14,ST37. With participant supine, 0.30 mm×50 mm or 0.35mm×75mm needles were inserted into ST25 and SP14 slowly and vertically, without manipulation, for approximately 30 to 70mm until they pierced the muscle layer of the abdominal wall. EA apparatus were attached transversely to bilateral ST25 and SP14, lasted for 30 minutes with a dilatational wave of 10/50Hz and current intensity of 0.1 to 1 mA depending on participant's comfort level. 0.30mm × 40mm needles were inserted into ST37 vertically for about 30mm and three small, equal manipulations of twirling, lifting, and thrusting were performed to reach acupuncture de qi.</description>
          </group>
          <group group_id="O2">
            <title>Sham Electro-acupuncture</title>
            <description>Sham Electroacupuncture (SA) group consisted of 28 sessions of 30 minutes' duration, each administered over a period of 8 weeks (five sessions in each of the first 2 weeks, followed by 3 sessions per week in the remaining 6 weeks). Huatuo disposable needles and EA apparatus, type SDZ-V (Suzhou Medical Appliance, China) were used. Participants in SA group received needling at bilateral non-acupoints of sham ST25, sham SP14, sham ST37. Specifically, 0.30 mm × 25 mm needles were used to penetrate the skin vertically at approximately 3 to 5 mm without any manipulation. Similar to EA group, paired alligator clips from the specially constructed EA apparatus were attached to the needle holders. When switched on, the EA apparatus in the SA group had the same working power indicator and sound but no actual current output. Additionally, 0.30 mm × 25 mm needles were inserted into sham ST37 vertically at about 3 - 5 mm without manipulation.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Adverse Events Related to Acupuncture</title>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="536"/>
                <count group_id="O2" value="539"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31"/>
                    <measurement group_id="O2" value="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean of Weekly Frequency of Rescue Medicine and Other Defecation Assistances Used</title>
        <description>Rescue medicine for constipation during the trial will be recorded. For rescue medicine, any participants experiencing no bowel movements for 3 or more consecutive days during the whole trial period were allowed to use a 110 ml glycerol anal enema or 40-60 ml sorbitol anal enema as a rescue medicine with documentation in the stool diary.Other If a patient used other medicine, it should be also recorded in the diary.Only the frequences of rescue medicine and other medicine for constipation will be recorded in diary by patient. Weekly frequencies were combined across Weeks 1-8 and 9-20 per participant by averaged across all measurements.</description>
        <time_frame>1-20 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Electro-acupuncture</title>
            <description>Electroacupuncture (EA) group consisted of 28 sessions of 30 minutes' duration, each administered over a period of 8 weeks. Huatuo disposable needles and EA apparatus, type SDZ-V(Suzhou Medical Appliance, China) were used. Participants in the EA group received EA at bilateral acupoints of ST25, SP14,ST37. With participant supine, 0.30 mm×50 mm or 0.35mm×75mm needles were inserted into ST25 and SP14 slowly and vertically, without manipulation, for approximately 30 to 70mm until they pierced the muscle layer of the abdominal wall. EA apparatus were attached transversely to bilateral ST25 and SP14, lasted for 30 minutes with a dilatational wave of 10/50Hz and current intensity of 0.1 to 1 mA depending on participant's comfort level. 0.30mm × 40mm needles were inserted into ST37 vertically for about 30mm and three small, equal manipulations of twirling, lifting, and thrusting were performed to reach acupuncture de qi.</description>
          </group>
          <group group_id="O2">
            <title>Sham Electro-acupuncture</title>
            <description>Sham Electroacupuncture (SA) group consisted of 28 sessions of 30 minutes' duration, each administered over a period of 8 weeks (five sessions in each of the first 2 weeks, followed by 3 sessions per week in the remaining 6 weeks). Huatuo disposable needles and EA apparatus, type SDZ-V (Suzhou Medical Appliance, China) were used. Participants in SA group received needling at bilateral non-acupoints of sham ST25, sham SP14, sham ST37. Specifically, 0.30 mm × 25 mm needles were used to penetrate the skin vertically at approximately 3 to 5 mm without any manipulation. Similar to EA group, paired alligator clips from the specially constructed EA apparatus were attached to the needle holders. When switched on, the EA apparatus in the SA group had the same working power indicator and sound but no actual current output. Additionally, 0.30 mm × 25 mm needles were inserted into sham ST37 vertically at about 3 - 5 mm without manipulation.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean of Weekly Frequency of Rescue Medicine and Other Defecation Assistances Used</title>
          <description>Rescue medicine for constipation during the trial will be recorded. For rescue medicine, any participants experiencing no bowel movements for 3 or more consecutive days during the whole trial period were allowed to use a 110 ml glycerol anal enema or 40-60 ml sorbitol anal enema as a rescue medicine with documentation in the stool diary.Other If a patient used other medicine, it should be also recorded in the diary.Only the frequences of rescue medicine and other medicine for constipation will be recorded in diary by patient. Weekly frequencies were combined across Weeks 1-8 and 9-20 per participant by averaged across all measurements.</description>
          <units>number of times per week</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="536"/>
                <count group_id="O2" value="539"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 1-8：Rescue medicine</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.34" spread="0.04"/>
                    <measurement group_id="O2" value="0.52" spread="0.06"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 1-8：others</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.02" spread="0.01"/>
                    <measurement group_id="O2" value="0.02" spread="0.01"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week9-20：Rescue medicine</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.25" spread="0.04"/>
                    <measurement group_id="O2" value="0.37" spread="0.05"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 9-20：others</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.02" spread="0.01"/>
                    <measurement group_id="O2" value="0.06" spread="0.02"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>The Number of Participants Using Rescue Medicine for Constipation</title>
        <time_frame>1-20 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Electro-acupuncture</title>
            <description>Electroacupuncture (EA) group consisted of 28 sessions of 30 minutes' duration, each administered over a period of 8 weeks. Huatuo disposable needles and EA apparatus, type SDZ-V(Suzhou Medical Appliance, China) were used. Participants in the EA group received EA at bilateral acupoints of ST25, SP14,ST37. With participant supine, 0.30 mm×50 mm or 0.35mm×75mm needles were inserted into ST25 and SP14 slowly and vertically, without manipulation, for approximately 30 to 70mm until they pierced the muscle layer of the abdominal wall. EA apparatus were attached transversely to bilateral ST25 and SP14, lasted for 30 minutes with a dilatational wave of 10/50Hz and current intensity of 0.1 to 1 mA depending on participant's comfort level. 0.30mm × 40mm needles were inserted into ST37 vertically for about 30mm and three small, equal manipulations of twirling, lifting, and thrusting were performed to reach acupuncture de qi.</description>
          </group>
          <group group_id="O2">
            <title>Sham Electro-acupuncture</title>
            <description>Sham Electroacupuncture (SA) group consisted of 28 sessions of 30 minutes' duration, each administered over a period of 8 weeks (five sessions in each of the first 2 weeks, followed by 3 sessions per week in the remaining 6 weeks). Huatuo disposable needles and EA apparatus, type SDZ-V (Suzhou Medical Appliance, China) were used. Participants in SA group received needling at bilateral non-acupoints of sham ST25, sham SP14, sham ST37. Specifically, 0.30 mm × 25 mm needles were used to penetrate the skin vertically at approximately 3 to 5 mm without any manipulation. Similar to EA group, paired alligator clips from the specially constructed EA apparatus were attached to the needle holders. When switched on, the EA apparatus in the SA group had the same working power indicator and sound but no actual current output. Additionally, 0.30 mm × 25 mm needles were inserted into sham ST37 vertically at about 3 - 5 mm without manipulation.</description>
          </group>
        </group_list>
        <measure>
          <title>The Number of Participants Using Rescue Medicine for Constipation</title>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="536"/>
                <count group_id="O2" value="539"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 1-8：Rescue medicine</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="155"/>
                    <measurement group_id="O2" value="183"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 1-8：others</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15"/>
                    <measurement group_id="O2" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week9-20：Rescue medicine</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="104"/>
                    <measurement group_id="O2" value="124"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 9-20：others</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                    <measurement group_id="O2" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Weekly Frequency of Rescue Medicine and Other Defecation Assistances Used</title>
        <description>Rescue medicine for constipation during the trial will be recorded. For rescue medicine, any participants experiencing no bowel movements for 3 or more consecutive days during the whole trial period were allowed to use a 110 ml glycerol anal enema or 40-60 ml sorbitol anal enema as a rescue medicine with documentation in the stool diary.Other If a patient used other medicine, it should be also recorded in the diary.Only the frequences of rescue medicine and other medicine for constipation will be recorded in diary by patient. Weekly frequencies were combined across Weeks 1-8 and 9-20 per participant by averaged across all measurements.</description>
        <time_frame>1-20 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Electro-acupuncture</title>
            <description>Electroacupuncture (EA) group consisted of 28 sessions of 30 minutes' duration, each administered over a period of 8 weeks. Huatuo disposable needles and EA apparatus, type SDZ-V(Suzhou Medical Appliance, China) were used. Participants in the EA group received EA at bilateral acupoints of ST25, SP14,ST37. With participant supine, 0.30 mm×50 mm or 0.35mm×75mm needles were inserted into ST25 and SP14 slowly and vertically, without manipulation, for approximately 30 to 70mm until they pierced the muscle layer of the abdominal wall. EA apparatus were attached transversely to bilateral ST25 and SP14, lasted for 30 minutes with a dilatational wave of 10/50Hz and current intensity of 0.1 to 1 mA depending on participant's comfort level. 0.30mm × 40mm needles were inserted into ST37 vertically for about 30mm and three small, equal manipulations of twirling, lifting, and thrusting were performed to reach acupuncture de qi.</description>
          </group>
          <group group_id="O2">
            <title>Sham Electro-acupuncture</title>
            <description>Sham Electroacupuncture (SA) group consisted of 28 sessions of 30 minutes' duration, each administered over a period of 8 weeks (five sessions in each of the first 2 weeks, followed by 3 sessions per week in the remaining 6 weeks). Huatuo disposable needles and EA apparatus, type SDZ-V (Suzhou Medical Appliance, China) were used. Participants in SA group received needling at bilateral non-acupoints of sham ST25, sham SP14, sham ST37. Specifically, 0.30 mm × 25 mm needles were used to penetrate the skin vertically at approximately 3 to 5 mm without any manipulation. Similar to EA group, paired alligator clips from the specially constructed EA apparatus were attached to the needle holders. When switched on, the EA apparatus in the SA group had the same working power indicator and sound but no actual current output. Additionally, 0.30 mm × 25 mm needles were inserted into sham ST37 vertically at about 3 - 5 mm without manipulation.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Weekly Frequency of Rescue Medicine and Other Defecation Assistances Used</title>
          <description>Rescue medicine for constipation during the trial will be recorded. For rescue medicine, any participants experiencing no bowel movements for 3 or more consecutive days during the whole trial period were allowed to use a 110 ml glycerol anal enema or 40-60 ml sorbitol anal enema as a rescue medicine with documentation in the stool diary.Other If a patient used other medicine, it should be also recorded in the diary.Only the frequences of rescue medicine and other medicine for constipation will be recorded in diary by patient. Weekly frequencies were combined across Weeks 1-8 and 9-20 per participant by averaged across all measurements.</description>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="536"/>
                <count group_id="O2" value="539"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Week 1-8：Rescue medicine</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28.92"/>
                    <measurement group_id="O2" value="33.95"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 1-8：others</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.8"/>
                    <measurement group_id="O2" value="3.15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week9-20：Rescue medicine</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19.40"/>
                    <measurement group_id="O2" value="23.01"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Week 9-20：others</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.24"/>
                    <measurement group_id="O2" value="3.15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>All through the study</time_frame>
      <desc>All Adverse events（AE）were recorded and measured by both participants themselves and acupuncturists.3 cases(2 in electro-acupuncture(EA)group and 1 in sham EA group)dropped out of this research before getting any intervention for effect,only having baseline data.Multipl imputation was adopted for these 3 in outcome measure part,but not for AE part.</desc>
      <group_list>
        <group group_id="E1">
          <title>Electro-acupuncture</title>
          <description>Electroacupuncture (EA) group consisted of 28 sessions of 30 minutes' duration, each administered over a period of 8 weeks. Huatuo disposable needles and EA apparatus, type SDZ-V(Suzhou Medical Appliance, China) were used. Participants in the EA group received EA at bilateral acupoints of ST25, SP14,ST37. With participant supine, 0.30 mm×50 mm or 0.35mm×75mm needles were inserted into ST25 and SP14 slowly and vertically, without manipulation, for approximately 30 to 70mm until they pierced the muscle layer of the abdominal wall. EA apparatus were attached transversely to bilateral ST25 and SP14, lasted for 30 minutes with a dilatational wave of 10/50Hz and current intensity of 0.1 to 1 mA depending on participant's comfort level. 0.30mm × 40mm needles were inserted into ST37 vertically for about 30mm and three small, equal manipulations of twirling, lifting, and thrusting were performed to reach acupuncture de qi.</description>
        </group>
        <group group_id="E2">
          <title>Sham Electro-acupuncture</title>
          <description>Sham Electroacupuncture (SA) group consisted of 28 sessions of 30 minutes' duration, each administered over a period of 8 weeks (five sessions in each of the first 2 weeks, followed by 3 sessions per week in the remaining 6 weeks). Huatuo disposable needles and EA apparatus, type SDZ-V (Suzhou Medical Appliance, China) were used. Participants in SA group received needling at bilateral non-acupoints of sham ST25, sham SP14, sham ST37. Specifically, 0.30 mm × 25 mm needles were used to penetrate the skin vertically at approximately 3 to 5 mm without any manipulation. Similar to EA group, paired alligator clips from the specially constructed EA apparatus were attached to the needle holders. When switched on, the EA apparatus in the SA group had the same working power indicator and sound but no actual current output. Additionally, 0.30 mm × 25 mm needles were inserted into sham ST37 vertically at about 3 - 5 mm without manipulation.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="534"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="538"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="31" subjects_at_risk="534"/>
                <counts group_id="E2" subjects_affected="24" subjects_at_risk="538"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Left needle</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="534"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="538"/>
              </event>
              <event>
                <sub_title>Nausea during acupuncture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="534"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="538"/>
              </event>
              <event>
                <sub_title>Faint during acupuncture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="534"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="538"/>
              </event>
              <event>
                <sub_title>Unbearable pricking (VAS≥8)</sub_title>
                <counts group_id="E1" events="5" subjects_affected="3" subjects_at_risk="534"/>
                <counts group_id="E2" events="6" subjects_affected="5" subjects_at_risk="538"/>
              </event>
              <event>
                <sub_title>Pricking lasted more than 0.5 hour</sub_title>
                <counts group_id="E1" events="5" subjects_affected="2" subjects_at_risk="534"/>
                <counts group_id="E2" events="3" subjects_affected="1" subjects_at_risk="538"/>
              </event>
              <event>
                <sub_title>Hematoma around the site of needling</sub_title>
                <counts group_id="E1" events="40" subjects_affected="19" subjects_at_risk="534"/>
                <counts group_id="E2" events="31" subjects_affected="17" subjects_at_risk="538"/>
              </event>
              <event>
                <sub_title>Bleeding/numbness/infection around the site of needling</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="534"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="538"/>
              </event>
              <event>
                <sub_title>Sleeplessness after acupuncture</sub_title>
                <counts group_id="E1" events="27" subjects_affected="1" subjects_at_risk="534"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="538"/>
              </event>
              <event>
                <sub_title>Dizziness after acupuncture</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="534"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="538"/>
              </event>
              <event>
                <sub_title>Other discomforts after acupuncture</sub_title>
                <counts group_id="E1" events="9" subjects_affected="7" subjects_at_risk="534"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="538"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>The 8-week treatment and 12-week follow-up may not be long enough for EA to show its specific therapeutic effect. Efficacy of electro-acupuncture in relieving severe constipation was evaluated without classifying the types of constipation.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Liu Zhishun</name_or_title>
      <organization>Guang An Men Hosptial of China Academy of Chinese Medical Sciences</organization>
      <phone>86 13651016313</phone>
      <email>liuzhishun@hotmail.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01726504
org study id: 2012BAI24B01
nct id: NCT01726504
lead sponsor: 
collaborator: 
has dmc: Yes
The main purpose of this study is to evaluate efficacy of electro-acupuncture for severe
      functional constipation compared with sham acupuncture, used as placebo; the secondary
      purpose is to evaluate the safety and post-treatment effect of electro-acupuncture.
Chronic functional constipation is a common disease. To date there has not specific therapy
      on chronic functional constipation. Systematic reviews indicate that acupuncture is probably
      effective for the disease, but the evidence is limited. Recently, we have finished a
      multi-center clinical trial of individualized deep electro-acupuncture (EA) for chronic
      functional constipation (n=460, Registration ID: NCT00508482) which preliminarily showed EA
      was effective.

      This multi-center large-sample randomized controlled clinical trial of acupuncture for severe
      functional constipation is designed to confirm the efficacy and safety of EA.

      This project is conducted by Chinese experts, supported by the Chinese Government. The
      research result is expected to provide high quality evidence of EA for chronic functional
      constipation.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: the Change in Mean Weekly CSBMs During Weeks 1-8 Since Treatment
time frame: Baseline and weeks 1-8
description: the change number in mean weekly CSBMs during weeks 1-8 since treatment compared with baseline.
measure: the Percentage of Participants With Three or More Weekly CSBMs
time frame: 1-20 weeks
description: the percentage of participants with three or more weekly CSBMs during weeks 1-8 and weeks 9-20
measure: Changes in Mean Weekly CSBMs During Weeks 9-20
time frame: Baseline and weeks 9-20
description: The changed number in mean weekly average CSBMs during 9-20th weeks, compared with baseline.
measure: Mean Weekly SBMs During Weeks 1-8
time frame: Baseline and weeks 1-8
description: The changed number in mean of weekly average SBMs (spontaneous bowel movement) during 8-week treatment, compared with baseline.
measure: Mean Scores for Stool Consistency and Straining During Weeks 1-8
time frame: Baseline and weeks 1-8
description: average weekly stool consistency (Bristol Stool Scale) assessment of self-defecation during the 1-8weeks of treatment,compared with baseline. Bristol Stool Scale including 7-type, scored by 1 to 7 respectively.Type 1: Separate hard lumps, like nuts (hard to pass); Type 2: Sausage-shaped, but lumpy; Type 3: Like a sausage but with cracks on its surface; Type 4: Like a sausage or snake, smooth and soft; Type 5: Soft blobs with clear cut edges (passed easily); Type 6: Fluffy pieces with ragged edges, a mushy stool; Type 7: Watery, no solid pieces. Entirely liquid. Type 3, 4 are normal.
measure: Change of Average Weekly Degree of Difficulty in Defecation From Baseline
time frame: Baseline and weeks 1-8
description: The degree of straining during self-defecation: The severity of straining is graded using a 4-point ordinal scale.
0 = not at all
= more straining than not
= a great deal
= an extreme amount, need finger manipulation to defecate average weekly degree of difficulty in self-defecation during 1-8weeks,compared with baseline
measure: Then Change Score of Health-related Quality of Life Via Patient-Assessment of Constipation Quality Of Life (PAC-QOL)
time frame: baseline and the end of 8th week
description: Patient-Assessment of Constipation Quality Of Life(PAC-QOL) ranges are 28-140,and higher values represent a worse outcome.Subscales are summed to compute the total score. The changed score of PAC-QOL at week 8, compared with baseline.
measure: Number of Participants With Adverse Events Related to Acupuncture
time frame: 1-8 weeks
measure: Mean of Weekly Frequency of Rescue Medicine and Other Defecation Assistances Used
time frame: 1-20 weeks
description: Rescue medicine for constipation during the trial will be recorded. For rescue medicine, any participants experiencing no bowel movements for 3 or more consecutive days during the whole trial period were allowed to use a 110 ml glycerol anal enema or 40-60 ml sorbitol anal enema as a rescue medicine with documentation in the stool diary.Other If a patient used other medicine, it should be also recorded in the diary.Only the frequences of rescue medicine and other medicine for constipation will be recorded in diary by patient. Weekly frequencies were combined across Weeks 1-8 and 9-20 per participant by averaged across all measurements.
measure: The Number of Participants Using Rescue Medicine for Constipation
time frame: 1-20 weeks
measure: Percentage of Weekly Frequency of Rescue Medicine and Other Defecation Assistances Used
time frame: 1-20 weeks
description: Rescue medicine for constipation during the trial will be recorded. For rescue medicine, any participants experiencing no bowel movements for 3 or more consecutive days during the whole trial period were allowed to use a 110 ml glycerol anal enema or 40-60 ml sorbitol anal enema as a rescue medicine with documentation in the stool diary.Other If a patient used other medicine, it should be also recorded in the diary.Only the frequences of rescue medicine and other medicine for constipation will be recorded in diary by patient. Weekly frequencies were combined across Weeks 1-8 and 9-20 per participant by averaged across all measurements.
arm group label: electro-acupuncture
arm group type: Experimental
description: The electric stimulator is applied to bilateral ST25andSP14 with dilatational wave10/50 Hz and electric current0.1-1.0mA.They are given acupuncture with 0.3×50mm or 0.35×75mm needles by inserting30-70mm and twirling lifting andthrusting 3 times.Dosage:The needle arrives the abdominal muscle layer(patients feel painful and acupuncturists feel touching hard).
Bilateral ST37 are given conventional acupuncture with 0.30mm×40mm needles by inserting 25-30mm and twirling lifting and thrusting for 3.Dosage:Local sour and heavy feeling is the appropriate dose.
Every session lasts for 30min/day.The participants are treated continuously for 8 weeks.During 8-week treatment the first 2 weeks,5 sessions per week,and 3 sessions per week in the rest 6 weeks,28 sessions for each patients in total.
arm group label: sham electro-acupuncture
arm group type: Sham Comparator
description: The electric stimulator is applied to bilateral sham ST25 and sham SP14 with dilatational wave, 10/50 Hz and electric current 0.5mA. The mental wire has been cut off with a same outlook as the treatment group. The electric stimulator is looked normal but with no current output. The needle is inserted by 3mm-5mm (the needle can be vertically fixed on the skin).
Bilateral ST37 are given acupuncture with 3mm-5mm (the needle can be vertically fixed on the skin).
Length of Treatment and the treatment sessions are the same as treatment group.
intervention type: Device
intervention name: electro-acupuncture
description: Procedure: electro-acupuncture; Points:Tianshu (ST25) Fujie(SP14), Shangjuxu (ST37).Pierced the skin, needles are inserted 30to70mm into bilateral ST25 and SP14 vertically until piercing the abdominal muscle layer.Electric stimulator is applied to bilateral ST25 and SP14 with dilatational wave, 10/50 Hz and electric current 0.1-1.0mA. The participant's abdominal muscle twitching mildly is the appropriate dose. Bilateral ST37 are inserted 25-30mm and then twirling lifting and thrusting for 3 times.Local sour and heavy feeling is appropriate dose. Steady small twirling lifting and thrusting 3 times in all. 30 min/per day/per session.During the 8 weeks treatment, the first 2 weeks,5 sessions per week, and 3 sessions per week in the rest 6 weeks,28 sessions for each patients in total.
arm group label: electro-acupuncture
other name: SDZ-V electro-acupuncture apparatus (Huatuo, made in China)
intervention type: Device
intervention name: sham electro-acupuncture
description: Procedure:sham electro-acupuncture;Points:Sham Tianshu(ST25),sham Fujie(SP14),sham Shangjuxu (ST37).Sham points location:20mm away from ST25,middle of Spleen and Stomach Channel;30mm from SP14,middle of Spleen and Stomach Channel; one point beside ST37,middle of Stomach and Gallbladder Channel; Performance:The needle is inserted with needle of 0.30×25mm by 3-5mm. No twirling lifting and thrusting. The electric stimulator is applied to bilateral sham ST25 and sham SP14 with dilatational wave,10/50 Hz and electric current 0.5mA.The mental wire has been cut off with a same outlook as the treatment group.The electric stimulator is looked normal but with no current output. Length of Treatment and the treatment sessions are the same as treatment group.
arm group label: sham electro-acupuncture
other name: Sham SDZ-V electro-acupuncture apparatus (Huatuo, China)
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Baoyan Liu, Master
role: Principal Investigator
affiliation: Vice President of China Academy of Chinese Medical Sciences
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
investigator full name: Liu Baoyan
investigator title: Vice President of China Academy of Chinese Medical Sciences
mesh term: Constipation
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: The 8-week treatment and 12-week follow-up may not be long enough for EA to show its specific therapeutic effect. Efficacy of electro-acupuncture in relieving severe constipation was evaluated without classifying the types of constipation.
point of contact: 