Constipation - Functional
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICEacupuncture
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.
DEVICEsham acupuncture
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.
Sponsors
Shanghai Municipal Hospital of Traditional Chinese Medicine
Longhua Hospital
Yin Ping
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
60 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Meet Rome IV Diagnostic Criteria for Constipation and TCM Diagnostic Criteria of constipation with yin deficiency syndrome; * No gender restriction, age 60-80; * FC that is classified as mild or moderate; * Have not used any medicine for constipation at least 2 weeks before treatment (except emergency treatment); * Have not participated in other medical clinical trials over the past one month; * Those who can understand various evaluation scales, complete the evaluation and cooperate with the completion of the planned course of treatment; * Sign the informed consent.
Exclusion criteria
* Irritable bowel syndrome and constipation caused by tumors, inflammatory reactions, endocrine and metabolic diseases, and drugs; * Constipation caused by organic diseases; * Patients with serious primary diseases such as heart, brain, liver, kidney and hematopoietic system, infectious diseases, tumors, and mental diseases; * Those who voluntarily give up or cannot cooperate with treatment and observation due to various circumstances; * Patients with cognitive impairment or aphasia; * Those who take other drugs during treatment, which affect the efficacy and judgment (except emergency treatment).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The change in the mean number of CSBMs per week compared to baseline during the 8-week treatment period | At baseline, week 4 (in treatment), week 8 (end of treatment), and the follow-up period (week 12 and week 20 after randomization). | Complete Spontaneous Bowel Movements (CSBMs) refers to the frequency of a bowel movement that occurred in the absence of laxatives or manipulation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Assessment of Constipation-Symptoms (PAC-SYM) | At baseline and at week 8 (end of treatment). | A scale to assess the condition of the patient's constipation-related symptoms |
| Patient Assessment of Constipation Quality of Life Questionnaire (PAC-QOL) | At baseline and at week 8 (end of treatment). | A brief but comprehensive assessment of the daily life quality of patients with FC, containing 28 items |
| Self-rating Anxiety Scale（SAS） | At baseline and at week 8 (end of treatment). | A measure of somatic symptoms associated with anxiety reactions. |
| Bristol Stool Scale | At baseline and at week 8 (end of treatment). | A scale to classify the patient's voluntary bowel movement stool. |
| Weekly usage of emergency bowel medications | At baseline and at week 8 (end of treatment). | The proportions of participants using medications and doses for emergency treatment |
| Incidence of adverse events | During 1-8 weeks | The adverse events (AEs) assessment aims at evaluating the AEs of acupuncture treatment. |
| Self-rating Depression Scale（SDS） | At baseline and at week 8 (end of treatment). | A self-rating scale to assess patients' depression |
Countries
China
Outcome results
None listed