Clinical efficacy of the shallow puncture and more-twirling acupuncture method in migraine treatment and its effects on serum 5-HT and β-EP levels
Abstract
BACKGROUND:
The incidence rate for migraine is 12% worldwide, and recurrence is common, which seriously affects the physical and mental health of patients.
OBJECTIVE:
To observe the clinical effect of Shallow Puncture and More Twirling method of acupuncture in treating migraine and its impact on serum 5-HT and
METHODS:
A total of 76 patients with migraine were randomized into a control group and acupuncture group with 38 cases in each. In the control group, patients were orally administered flunarizine hydrochloride before sleep, 2 capsules once daily for 4 weeks. In the acupuncture group, Shallow Puncture and More Twirling method was adopted for the acupoints of Sizhukong (SJ 23), Toulinqi (GB 15) Shuaigu (GB 8), Xuanlu (GB 5), Fengchi (GB 20), Waiguan (SJ 5), Zulinqi (GB 41). Patients were given acupuncture 3 times per week for 4 weeks. Then, the total VAS (Visual Analogue Scale) scores, composite score of migraine, serum level of 5-HT and
RESULTS:
The total VAS scores and composite score of migraine were significantly reduced among both groups after the treatment (
CONCLUSION:
Shallow Puncture and More Twirling method was superior to flunarizine hydrochloride in the treatment of clinical symptoms of migraine. Acupuncture also increases the serum level of 5-HT and
1.Introduction
Migraine is a neurological disorder characterized by recurrent unilateral or bilateral attacks of moderate-to-severe headache that may be accompanied by nausea, fear of sound, and photophobia [1]. The incidence rate for migraine is 12% worldwide [2], and recurrence is common, which seriously affects physical and mental health of patients [3]. The World Health Organization (WHO) considers migraine the most disabling chronic disease [4]. Current medications for migraine are prone to drug resistance, addiction and toxic and side effects [5], whereas acupuncture shows efficacy with few adverse reactions in treating migraine [6] and thus has been listed as a recommended therapy by the WHO [7]. Based on the cutaneous region theory in Huangdi’s Internal Classics, the “shallow puncture and more-twirling” acupuncture method was developed by Doctor Chen Lei, a famous Chinese medicine expert in Zhejiang Province. This method is effective in treating migraine [8, 9], but the mechanism of action has not been elucidated. As a neurotransmitter and humoral transmitter, 5-HT is involved in important pathways for migraine in the central and peripheral areas.
This study is a single-center, evaluator-blinded, randomized controlled trial to observe the effects of the shallow puncture and more-twirling method on patients with migraine (as determined using the visual analog scale (VAS) score and comprehensive headache score) and to measure serum 5-hydroxytryptamine (5-HT) and beta-endorphin (
2.Materials and methods
2.1General data
Seventy-six patients with migraine who visited our hospital from June 2020 to March 2022 were enrolled and randomly assigned to a control group (medication,
Table 1
Group | No. of patients | Gender | Age (years) | Duration of disease (years) | |
---|---|---|---|---|---|
Male [ | Female [ | ||||
Control group | 38 | 19 (51.4) | 18 (48.6) | 43.82 | 3.41 |
Acupuncture group | 38 | 16 (43.2) | 21 (56.8) | 42.73 | 3.82 |
2.2Diagnostic criteria
Patients were diagnosed with migraine in accordance with the diagnostic criteria in the International Classification of Headache Disorders (ICHD-3) [1] formulated by the International Headache Society (IHS) in 2013.
2.3Inclusion criteria
The inclusion criteria were as follows: (1) patients who met the diagnostic criteria, (2) patients with
2.4Exclusion criteria
The exclusion criteria were as follows: (1) pregnant or lactating women, (2) patients with serious primary diseases of the brain and organs (heart, liver, kidney and hematopoietic system), e.g., Parkinson’s disease, extrapyramidal diseases or psychiatric disorders, (3) patients with specific types of migraine complications (e.g., ophthalmoplegia and hemiplegic), and (4) patients with a history of oral administration of preventive drugs or abuse of drugs for migraine within 1 month before enrollment.
2.5Criteria for trial suspension
The criteria for trial suspension included the following: (1) adverse events or serious adverse events during the trial, (2) poor compliance, (3) request to withdraw from the trial or voluntary withdrawal from the trial, and (4) taking other analgesic drugs during the trial.
3.Methods
3.1Treatment protocols
3.1.1Control group
Patients in the control group were orally administered flunarizine hydrochloride capsules (strength: 5 mg/capsule; approval No.: NMPA H10930003; manufacturer: Xian Janssen Pharmaceutical Ltd.) before sleep (2 capsules once daily for 4 weeks).
3.1.2Acupuncture group
Patients in the acupuncture group were treated with acupuncture using the shallow puncture and more-twirling method. The acupuncture points included Sizhukong (affected side), Toulinqi (affected side), Shuaigu (affected side), Xuanlu (affected side), Fengchi (affected side), Waiguan (affected side), and Zulinqi (affected side). First, the patient lay in a lateral position with the affected side upwards. Then, the acupuncture points were routinely disinfected, and 0.25
3.2Observation indicators
3.2.1VAS score
The VAS score was recorded before and after treatment using the following method. A 10-cm horizontal line was drawn on paper, and numbers from 0 to 10 were marked at 1-cm intervals. Numbers from “0” (no pain) to “10” (severe pain) represented a gradual increase in pain.
3.2.2Comprehensive headache score
The comprehensive headache score was evaluated before and after treatment with reference to the Guiding Principles for Clinical Research of New Chinese Medicines [10]. Headache was scored based on its degree (6 points for requiring bed rest during the attack, 4 points for affecting work, 2 points for not affecting work, and 0 points for no headache), duration of pain (0 points for no headache, 1 point for less than 2 hours, 2 points for 2–6 hours, 3 points for 6–24 hours, 4 points for 24–72 hours, and 5 points for longer than 72 hours), number of attacks (6 points for more than 5 times/month, 4 points for 3–4 times/month, 2 points for 1–2 times/month, and 0 points for no attacks), and concomitant symptoms (3 points for nausea, vomiting and photophobia, 2 points for 2 of the above symptoms, 1 point for one of the above symptoms, and 0 points for no concomitant symptoms).
3.2.3Serum 5-hydroxytryptamine (5-HT) and beta-endorphin (β -EP) levels
Before and after treatment, 5 mL of nonanticoagulated blood was collected from the elbow vein of each patient in both groups. After sitting for 15 min, the blood samples were centrifuged at high speed, and the supernatant was harvested and stored in a freezer at
3.3Evaluation criteria for clinical efficacy
Clinical efficacy was evaluated using the nimodipine method with reference to the Guiding Principles for Clinical Research of New Chinese Medicines [10]. The calculation formula (nimodipine method) was as follows: [(pretreatment comprehensive headache score – posttreatment comprehensive headache score)/pretreatment comprehensive headache score]
3.4Safety evaluation
Adverse events (including local hematoma, fainting during acupuncture, sticking of needles, and infections) occurring during treatment as well as their extent and duration were observed and recorded.
3.5Statistical analysis
SPSS 22.0 software was used for statistical analyses. Measurement data are expressed as (
4.Computer simulation and results
4.1Comparisons of VAS scores and comprehensive headache scores between the 2 groups
Before treatment, the VAS scores and comprehensive headache scores were not significantly different and thus were comparable between the 2 groups (
Table 2
Group | Patients | VAS score (points) | Comprehensive headache score (points) | ||
---|---|---|---|---|---|
Before treatment | After treatment | Before treatment | After treatment | ||
Control group | 38 | 6.53 | 3.82 | 15.32 | 8.13 |
Acupuncture group | 38 | 6.24 | 2.63 | 15.08 | 4.89 |
Note:
4.2Comparisons of serum 5-HT and β -EP levels
Before treatment, there were no statistically significant differences in serum 5-HT and
Table 3
Group | Patients | 5-HT | |||
---|---|---|---|---|---|
Before treatment | After treatment | Before treatment | After treatment | ||
Control group | 38 | 61.56 | 119.69 | 156.2 | 209.36 |
Acupuncture group | 38 | 61.45 | 147.99 | 154.19 | 245.49 |
Note:
4.3Comparison of clinical efficacy between the 2 groups
After treatment, the significantly effective rate, effective rate, ineffective rate and total effective rate were 21.6%, 56.8%, 21.61% and 78.4%, respectively, in the control group. On the contrast, the clinical cure rate, significantly effective rate, effective rate, ineffective rate and total effective rate were 5.4%, 43.2%, 37.8%, 15.5% and 86.5%, respectively, in the acupuncture group. The total effective rate was higher in the acupuncture group than in the control group (
Table 4
Group | Patients | Clinical cure | Significantly effective | Effective | Ineffective | Total effective rate (%) |
---|---|---|---|---|---|---|
Control group | 38 | 0 | 8 (21.6%) | 21 (56.8%) | 8 (21.6%) | 78.4 |
Acupuncture group | 38 | 2 (5.4%) | 16 (43.2%) | 14 (37.8%) | 5 (13.5%) | 86.5 |
Note:
4.4Safety evaluation
No adverse events occurred in the acupuncture group during treatment, indicating that this acupuncture method is relatively safe.
5.Conclusion
Migraine is classified as “headache” and “head wind” in traditional Chinese medicine. Headache can be divided into 2 types based on causative factors: external contraction and internal damage. “The top part is first attacked in individuals who are affected by wind pathogen,” and “only the wind can reach the high top.” Wind pathogen is considered the main causative factor for headache, regardless of external contraction or internal damage. The first to be affected by the invasion of wind pathogen is the cutaneous region and then from the exterior to the interior, passing through the meridians into the zang-fu organs. As described in Plain Questions – Cutaneous Region Theory, “if the skin is attacked by the pathogenic qi, the striae and interstices will open, and then, the pathogenic qi will enter the collateral vessels, followed by meridians and zang-fu organs”. Hence, the invasion path of pathogenic qi is from the cutaneous region to collateral vessels, meridians and zang-fu organs. The cutaneous region is the most superficial part of the meridian system and is the gateway of pathogenic qi in the body, contacting the body surface with the zang-fu organs, regulating the meridians, and opening and closing the striae and interstices. Therefore, relevant diseases can be treated via the function of the cutaneous region. The shallow puncture and more-twirling acupuncture method is an approach developed by Doctor Chen Lei, a famous Chinese medicine expert in Zhejiang Province, based on the cutaneous region theory. This method evolves from the traditional “skin needling method” and activates the meridian qi in the heaven of “heaven, human, and earth”, namely the superficial part of the transport points, creating an itchy or numb sensation on the skin, from local to peripheral positions and even to distal and diseased zang-fu organs, referred to as “qi reaching the lesion”. In addition, the shallow puncture method requires puncture of the skin first, the aim of which is to prevent the change in and block the entry and exit of the disease. After the retreating path of pathogenic qi is blocked, healthy qi is obtained, passing through the meridian system to activate the whole body meridian qi and intersect via multiple layers of pathways and to dispel the pathogenic qi. A significant wind-dispelling effect is then achieved. The more-twirling method enhances the regulatory effect of shallow puncture on the meridian points, activating blood and moving qi, so as to dispel wind pathogen by moving blood. The combination of these 2 methods can move blood to dispel wind and thus disperse pathogen, thus achieving an analgesic effect in treating migraine. Although the procedure seems simple, the needle should not be removed immediately once inserted. Moving and pushing qi occurs in the rapid twirling after the needle is inserted, thus unblocks meridians and harmonizes qi and the blood. For this reason, a fast and even twirl, the force applied by the needle tip and the maintenance of the needling sensation are crucial. Most doctors believe that the onset of migraine is related to wind, fire, phlegm, stasis and the deficiency of qi and blood, so traditional Chinese medicine treatment mostly adopts the method of dispelling wind, clearing fire, channeling and dissolving phlegm [11, 12]. Data analysis [13, 14] showed that the selection of migraine acupoints was mainly the Zushaoyang gallbladder meridian points, while Fengchi and Shuaigu were the main acupuncture point combinations. Studies [15] have shown that acupuncture points such as Sizhukong, Shuaigu, Fengchi can reduce intracranial blood flow velocity and improve the pain level of migraine patients.
In this study, patients with migraine were divided into two groups, and the effects of the two groups were compared by using the relevant scoring indicators. The results indicated that the VAS scores and comprehensive headache scores of patients in the acupuncture group markedly improved after treatment compared with before treatment and were superior to those in the control group, further demonstrating the definite clinical efficacy of the shallow puncture and more-twirling acupuncture method for the treatment of migraine. The results of the study are also consistent with relevant reports [16]. Compared with the gastrointestinal and other adverse effects that the drugs may cause, and combined with the research results, acupuncture for migraine has better clinical efficacy and lighter side effects which are more acceptable to patients.
Currently, there is no consensus on the pathogenesis of migraine, mainly involving the vascular theory, the cortical diffusion inhibition theory and the trigeminal vascular theory [17]. With in-depth research, the roles of 5-HT and
According to a modern neurological study, the analgesic effect of acupuncture is mainly based on the effect of acupuncture on the nervous system and neurotransmitters [19]. In addition to an increase in the secretion of morphine-like substances in the brain, acupuncture can also facilitate the secretion of 5-HT and
Acknowledgments
This research was supported by Zhejiang Traditional Chinese Medicine Science and Technology Plan Projects (2020ZB220, 2021ZT004); Chen Lei Prestigious TCM doctors’ inheritance studio (GZS2020038); NINGBO Medical & Health Leading Academic Discipline Project (2022-ZF01); and NINGBO Medical & Health Brand Discipline Project (PPXK2018-07).
Conflict of interest
None to report.
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