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Different Amounts of Moxibustion in the Treatment of DPN: A Clinical RCT Study
Condition(s) studied
Diabetic Peripheral NeuropathyPainMoxibustionRandomized Controlled Trial
Investigational drug(s) / intervention(s)
Moxibustion
Moxibustion: The recruited patients all received diabetes mellitus education. Patients with combined hypertension and hyperlipidemia received daily treatment to lower their blood pressure and blood lipids. The medication was based on their current self-medication, to keep their conditions under normal control. The drug treatment group received mecobalamin tablets and epalrestat orally for four weeks along with their daily treatment. Moxibustion 15-minute group: The selected acupoints of moxibustion are Zusanli(ST 36), Sanyinjiao(SP 6), Quchi(LI 11), and Kunlun(BL 60), moxa cones were pasted on the acupoints and moxibustion was applied by ignition, each time for 15 minutes at each acupoint, once every three days, twice a week, four consecutive weeks of treatment. The moxibustion 30-minute group except for the operating time will use the same intervention as above.
Study summary
This study aims to provide moxibustion treatment for diabetic peripheral neuropathy (DPN) and a reference for clinical treatment of DPN moxibustion. Patients will be randomly assigned to 3 clinical centers, 30 in each center, and then equally divided into 3 groups, including a drug treatment group, a 15-minute moxibustion group, and a 30-minute moxibustion group. Patients in the drug treatment group were given mecobalamin tablets and epalrestat at the same time of daily treatment (hypertension and hyperlipidemia combined with basic drug treatment) for 4 weeks. The frequency of moxibustion was 15/30 minutes per acupoint twice a week for 4 weeks. The results were evaluated during the baseline period (the day before the grouping), the treatment period (the end of the 8th treatment), and the follow-up period (a month after the end of treatment). The results of this part are expected to confirm the therapeutic effect of moxibustion on diabetic peripheral neuropathy. The results of this part will be expected to confirm the optimal amount of moxibustion in the treatment of diabetic peripheral neuralgia and provide a reference for the standardization of clinical treatment of moxibustion.
Eligibility
Inclusion Criteria:
1. History of diabetes mellitus;
2. Persistent pain and/or abnormal sensation in the extremities (at least in both lower limbs), decreased bilateral or unilateral ankle reflexes, decreased vibratory sensation (weaker in the medial ankle than in the medial tibial condyle), and decreased nerve conduction velocity on the affected side, and TCSS score \>5;
3. 18 years ≤ age ≤ 80 years;
4. Gender is not limited;
5. Those who have the ability of independent daily life and can cooperate to complete all the examinations;
6. Those who are conscious without serious mental diseases and cognitive disorders, and those who do not have serious cardiac, cerebral, hepatic, renal and other internal diseases;
7. Voluntary participation and signing of informed consent.
Exclusion Criteria:
1. Those with peripheral neuropathy, ulcers and gangrene of the limbs caused by various other reasons (e.g. hypothyroidism, alcohol, drugs, heredity, etc.), or those with a history of skin ulcers or lesions that do not heal easily;
2. Women who are in preparation for pregnancy, during pregnancy or breastfeeding;
3. Those with acute complications such as combined diabetic ketoacidosis, lactic acidosis, severe infections, etc.;
4. Those who suffer from serious liver or kidney damage or serious cardiovascular and cerebrovascular diseases (angina pectoris, myocardial infarction, multiple cerebral infarctions, cerebral haemorrhage, etc.);
5. Those who have scars or pigmentation on the skin of the testing site, which will affect the accuracy of the test;
6. Those who are participating in other acupuncture or drug clinical trials.
Primary outcome measure(s)
- Total clinical effectiveness — After treatment phase (the 4th week) and the follow-up period (the 5th-8th week)
Overall clinical effectiveness was assessed at 2 time points: after 4 weeks of treatment and during the follow-up period (the 6th week). It was classified into the following 3 grades according to the Guidelines for Clinical Study of New Chinese Medicines:
1. Cure: clinical symptoms such as limb numbness, coldness and chilling pain, sensory abnormalities, muscle weakness and muscle atrophy disappear, tendon reflexes return to normal, and the total score of TCSS is ≤ 5 points;
2. Effective: numbness of the limbs, cold and chilling pain, sensory abnormalities, muscle weakness myasthenia and other clinical symptoms significantly improved, tendon reflexes returned to normal, TCSS score level 2 or 1 level lower;
3. Ineffective: clinical symptoms did not improve or worsen, tendon reflexes were not elicited, and TCSS score grade did not decrease or increase.
Total effective rate = \[(number of cured cases + number of effective cases)/total number of cases\] × 100%.
Trial sites (3)
| Facility | City | Region | Status |
|---|
| The First Affiliated Hospital of Zhejiang Chinese Medicine University |
Hangzhou |
Zhejiang |
|
| The Third Affiliated Hospital of Zhejiang Chinese Medical University |
Hangzhou |
Zhejiang |
|
| Zhejiang Greentown Cardiovascular Hospital |
Hangzhou |
Zhejiang |
|
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