Efficacy and Safety of Acupuncture for Functional Constipation

• change from baseline in the Bristol Stool Scale at the 4th week [ Time Frame: at the 4th week ] [ Designated as safety issue: Yes ]
  type 1-7 corresponds to score 1-7, assess the average score of one week in the 4th week
• change from baseline in difficulty degree of defecation at the 4th week [ Time Frame: at the 4th week ] [ Designated as safety issue: No ]

  0—Without difficulty

  1. Defecation straining
  2. Severe defecation straining
  3. Defecation with the help of hands, assess the average score of one week in the 4th week
• change from baseline in SF-36 at the 4th week [ Time Frame: at the 4th week ] [ Designated as safety issue: No ]
  the MOS item Short From health survey
• change from baseline in SDS at the 4th week [ Time Frame: at the 4th week ] [ Designated as safety issue: No ]
  Self-rating Depression Scale
• change from baseline in unaided complete self-defecation frequency of a week at the 8th week [ Time Frame: at the 8th week ] [ Designated as safety issue: No ]
  frequencies of complete defecation of one week without the help of medication or hands
• change from baseline in the Bristol Stool Scale at the 8th week [ Time Frame: at the 8th week ] [ Designated as safety issue: No ]
  type 1-7 corresponds to score 1-7,assess the average score of one week in the 8th week
• change from baseline in difficulty degree of defecation at the 8th week [ Time Frame: at the 8th week ] [ Designated as safety issue: No ]

  0—Without difficulty

  1. Defecation straining
  2. Severe defecation straining
  3. Defecation with the help of hands, assess the average score of one week in the 8th week
• change from baseline in SAS at the 4th week [ Time Frame: at the 4th week ] [ Designated as safety issue: No ]
  Self-Rating Anxiety Scale

• change from baseline in the Bristol Stool Scale at the 4th week [ Time Frame: at the 4th week ] [ Designated as safety issue: Yes ]
  type 1-7 corresponds to score 1-7, assess the average score of one week in the 4th week
• change from baseline in difficulty degree of defecation at the 4th week [ Time Frame: at the 4th week ] [ Designated as safety issue: No ]

  0—Without difficulty

  1. Defecation straining
  2. Severe defecation straining
  3. Defecation with the help of hands, assess the average score of one week in the 4th week
• change from baseline in SF-36 at the 4th week [ Time Frame: at the 4th week ] [ Designated as safety issue: No ]
  the MOS item Short From health survey
• change from baseline in SDS at the 4th week [ Time Frame: at the 4th week ] [ Designated as safety issue: No ]
  Self-rating Depression Scale
• change from baseline in unaided self-defecation frequency of a week at the 8th week [ Time Frame: at the 8th week ] [ Designated as safety issue: No ]
  frequencies of defecation of one week without the help of medication or hands
• change from baseline in the Bristol Stool Scale at the 8th week [ Time Frame: at the 8th week ] [ Designated as safety issue: No ]
  type 1-7 corresponds to score 1-7,assess the average score of one week in the 8th week
• change from baseline in difficulty degree of defecation at the 8th week [ Time Frame: at the 8th week ] [ Designated as safety issue: No ]

  0—Without difficulty

  1. Defecation straining
  2. Severe defecation straining
  3. Defecation with the help of hands, assess the average score of one week in the 8th week
• change from baseline in SAS at the 4th week [ Time Frame: at the 4th week ] [ Designated as safety issue: No ]
  Self-Rating Anxiety Scale

A multi-center clinical trial done recently by us(NCT00508482) shows that needling on ST25 has the same effect as lactulose in unaided self-defecation frequency of a week and has better effect in symptoms improvement (in press). The object is to evaluate whether acupuncture is effective for functional constipation. As an explanatory research, it took one single point as its intervention and sham acupuncture as its control group (patients were blinded). On the basis of its confirmed effect, we are taking a pragmatic randomized controlled trial to further evaluate whether acupuncture is more effective than routine treatment. Acupuncture prescriptions used in this trial are individually prescribed according to syndrome differentiation, which can improve clinical effect. .

functional constipation,acupuncture,effects and safety,pragmatic RCT

• Other: acupuncture

  Thrust and lift the needle to achieve De Qi. After being needled, the points will be punctured again using auxiliary needles 2 mm lateral to the first needle, and to a depth of 2 mm without manual stimulation. Put the electric stimulator on the pair of needles with a continuous wave, 20Hz. The current intensity is increased to the patients' maximum tolerance and then slightly reduced to a bearable level (0.1-1.0 mA).

  Huatuo Brand needle (φ0.30×25mm,φ0.30×40mm,φ0.30×50mm, produced by Suzhou Medical Appliance Factory) and G6805-1A electro-acupuncture apparatus(produced by Shanghai Huayi Medical Instrument Co. Ltd.) will be used.

  Five sessions/week in the first 2 weeks, three sessions/week for in the last 2 weeks.

  Other Name: acupuncture and moxibustion
• Drug: mosapride citrate
  4-week oral use of mosapride citrate, 5mg, three times daily 0.5 hour before meal
  Other Name: mosapride citrate,made in China

• Experimental: Acupuncture at ST25 and BL25
  the points formula of back-shu point combination with front-mu point.
  Intervention: Other: acupuncture
• Experimental: Acupuncture at LI11 and ST37
  the points formula of He-points
  Intervention: Other: acupuncture
• Experimental: Acupuncture at ST25, BL25, LI11 and ST37
  the formula of He-point,back-shu point and front-mu point
  Intervention: Other: acupuncture
• Active Comparator: medicine
  oral use of mosapride citrate
  Intervention: Drug: mosapride citrate

Inclusion Criteria:

• Patients who has been diagnosed with functional constipation according to Rome Ⅲ criteria
• Patients who are aged 18-75 years old
• Stop medication or acupuncture (if any) 1 week before randomization and uninvolved in other trials
• Sign the informed consent out of one's own will

Exclusion Criteria:

• Secondary constipation
• Patients with consciousness impairment, psychotic patients or patients unable to express clearly
• Patients with malignant tumor in progressive stage, severe wasting disease and liable to be infected and bleed
• Patients with severe cardiovascular disease, hepatic injury, renal damage, digestive disease or hematological diseases
• Women in pregnancy and lactation period