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| Name | Class |
|---|---|
| Shanghai Municipal Hospital of Traditional Chinese Medicine | OTHER |
| Longhua Hospital | OTHER |
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Through a scientific and standardized randomized controlled study, we observe the effectiveness and safety of acupuncture in the treatment of functional constipation in the elderly through the method of "nourishing kidney and dredging Fu organs".
Functional constipation is a common disease of old people. To date, there has not specific therapy on it. Former research showed acupuncture may work for functional constipation. In the trial, patients in the acupuncture and sham acupuncture groups will receive 24 acupuncture treatments over an 8-week period. This RCT is designed to confirm the efficacy and safety of acupuncture in functional constipation treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acupuncture group | Experimental | Participants will receive acupuncture treatment at Zhao Hai(KI 6), Da Zhong(KI 4), Tai Xi(KI 3), Tian Shu(ST 25), and Shang Ju Xu(ST 37) bilaterally. Each treatment will last 30 minutes and participants will receive the treatment 3 times per week (every other day) for 8 weeks, 24 sessions in total. Follow-up time is week 4 and week 12 after treatment (ie, week 12 and week 20). |
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| Sham acupuncture group | Placebo Comparator | Participants will receive sham acupuncture treatment on bilateral sham Zhao Hai(KI 6), Da Zhong(KI 4), Tai Xi(KI 3), Tian Shu(ST 25), and Shang Ju Xu(ST 37) that match real acupuncture points. The duration of needle retention, treatment period, and follow-up in the control group is the same as that in the intervention group. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| acupuncture | Device | All acupoints will be routinely sterilized at first. After the insertion of the needles, manipulations of lifting, twirling, and thrusting are performed on all needles to reach de qi, which is a sensation typically associated with needling including soreness, numbness, swelling, heaviness, and other feelings. This is considered to be an important component of the therapeutic effect of acupuncture. |
| Measure | Description | Time Frame |
|---|---|---|
| The change in the mean number of CSBMs per week compared to baseline during the 8-week treatment period | Complete Spontaneous Bowel Movements (CSBMs) refers to the frequency of a bowel movement that occurred in the absence of laxatives or manipulation. | At baseline, week 4 (in treatment), week 8 (end of treatment), and the follow-up period (week 12 and week 20 after randomization). |
| Measure | Description | Time Frame |
|---|---|---|
| Bristol Stool Scale | A scale to classify the patient's voluntary bowel movement stool. | At baseline and at week 8 (end of treatment). |
| Patient Assessment of Constipation-Symptoms (PAC-SYM) | A scale to assess the condition of the patient's constipation-related symptoms |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| PING YIN | Shanghai University of Traditional Chinese Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Longhua Hospital | Shanghai | 200032 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21999154 | Background | Zhou K, Fang J, Wang X, Wang Y, Hong Y, Liu J, Wang L, Xue C, Wang P, Liu B, Zhu B. Characterization of de qi with electroacupuncture at acupoints with different properties. J Altern Complement Med. 2011 Nov;17(11):1007-13. doi: 10.1089/acm.2010.0652. Epub 2011 Oct 14. | |
| 32111187 | Background | Dunstan DA, Scott N. Norms for Zung's Self-rating Anxiety Scale. BMC Psychiatry. 2020 Feb 28;20(1):90. doi: 10.1186/s12888-019-2427-6. |
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| ID | Term |
|---|---|
| D015670 | Acupuncture Therapy |
| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
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| sham acupuncture | Device | The placebo needles chosen for this study are flat-tipped needles without a tip, which could not be pierced into the skin. In the meanwhile, an external patch device will fix the needles, which are visually pierced into the skin. After the treatment, the acupuncturist will press the acupuncture point with a dry cotton ball so that the patient can feel the pulling out of the "needle". |
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| At baseline and at week 8 (end of treatment). |
| Patient Assessment of Constipation Quality of Life Questionnaire (PAC-QOL) | A brief but comprehensive assessment of the daily life quality of patients with FC, containing 28 items | At baseline and at week 8 (end of treatment). |
| Self-rating Anxiety Scale（SAS） | A measure of somatic symptoms associated with anxiety reactions. | At baseline and at week 8 (end of treatment). |
| Self-rating Depression Scale（SDS） | A self-rating scale to assess patients' depression | At baseline and at week 8 (end of treatment). |
| Weekly usage of emergency bowel medications | The proportions of participants using medications and doses for emergency treatment | At baseline and at week 8 (end of treatment). |
| Incidence of adverse events | The adverse events (AEs) assessment aims at evaluating the AEs of acupuncture treatment. | During 1-8 weeks |
| 31185948 | Background | Dunstan DA, Scott N. Clarification of the cut-off score for Zung's self-rating depression scale. BMC Psychiatry. 2019 Jun 11;19(1):177. doi: 10.1186/s12888-019-2161-0. |