Effectiveness and Safety of Acupuncture for Short and Long Term Management of Migraine in Contrast To the Conventional Pharmacotherapeutic Drugs

Abstract

Objective:  The focus of this paper is to evaluate previous research studies on acupuncture for migraines with reference to the Standards for Reporting Interferences in precise trials of acupuncture strategies.

Scope:  The scope of this literature review is limited to reviewing the effectiveness and safety of various types of acupuncture for short and long-term management of migraines.

Method:  Resources utilized to complete the literature review consisted of reviewing numerous books, articles, and research journals focused on migraine and the field of acupuncture therapy.  To obtain a complete perspective of the efficacy of acupuncture therapy on patients with migraine, the literature reviewed encompassed any type of migraine as categorized by The International Classification of Headache Disorders (ICHD). In order to gain a true appreciation of the limited articles focusing on the effectiveness of acupuncture on migraine, exclusion criteria were eliminated.  After gathering the research articles, they were compared for similarities in research methodology, physiological measurements recorded, assessment tools utilized, and research outcomes.  If the frequency of migraine attacks was reduced by repeated sessions of acupuncture, then one can conclude that acupuncture has potential value for the treatment of migraine.  Furthermore, if the post-intervention results show a reduction in headache days and intensity on p-test or VAS score the evidence supporting acupuncture treatment as a therapeutically effective intervention is further strengthened. In addition, if the research previously performed and published in industry-recognized journals collectively concludes that acupuncture therapy reduces the symptoms of migraine headache without serious adverse effects when used for acute and chronic migraine attacks, then one can also conclude that acupuncture treatment is effective and safe for short- and long-term treatment of migraine.

Findings: Migraine is one of the major burdens in the United States, costing 6.5 to 17 billion US Dollars each year. The annual prevalence of migraine is 9.3% in China on average. The traditional therapy for migraine includes therapeutic drugs such as Non-steroidal Anti-inflammatory Drugs (NSAIDs), Ergotamines, Triptans, and Antiepileptics. However, this therapy comes with its own set of side effects including nausea, vomiting, tiredness, and insomnia, leading to patient noncompliance. This suggests a need for a shift to an alternative treatment that is effective for acute treatment, has long-lasting effects, and is short of adverse effects. Acupuncture has been one of the vital techniques in Traditional Chinese Medicine. It is commonly employed as a therapy for migraine in clinical practice. Acupuncture is also reported to be a widely used accompanying treatment globally. All the literature reviewed evaluated the effectiveness of acupuncture on migraine including its effects on frequency, intensity, and number of days of migraine as well as its safety for extended use. Studies utilized real or manual acupuncture as the test therapy and sham acupuncture or waiting list as the control group. Those reviews which evaluated the supremacy of real acupuncture over sham used sham acupuncture on the control group, most of which showed real acupuncture is superior to sham acupuncture for the treatment of migraine. Studies that evaluated the supremacy of pharmacotherapeutic drugs allocated drug therapy to a group of migraine patients. Acupuncture needles were used on specific acupoints for headache for the test group and non-specific acupoints for the control group. All research reviewed showed positive effects on migraine headaches with the use of acupuncture treatment without serious adverse events. Thus, acupuncture therapy may be an effective tool that provides the desired outcomes without negative side effects.

Conclusion: The preponderance of evidence reported within this paper suggests that acupuncture therapy reduces migraine and is safe for long term use. The therapeutic efficacy of real or manual acupuncture is significantly better than sham acupuncture for pain relief and can lead to a reduction in the use of acute traditional medication. Additionally, manual acupuncture is found to be safe and effective for short-term treatment of recurrent migraine attacks in adults as well as for its long-term management. However, there is room for more large-scale, high-quality research on manual acupuncture to be used as the main adjunct therapy that can limit the use of analgesics and other drug therapies to steer clear of their adverse effects.

Keywords

Keywords:  acupuncture, migraine, drug therapy, sham acupuncture, manual acupuncture, effectiveness of acupuncture on migraine, frequency of migraine attacks.

 

Introduction

Migraine is one of the most common brain disorders that cause disability in performance and productivity¹. The Global Burden of Disease Survey 2010 has graded migraine as the 3rd most prevailing ailment and the 7th highest source of incapacity globally^{2, 3}. Migraine is characterized by a one-sided, recurring headache that is throbbing in nature and is associated with nausea, photophobia, and/or phonophobia. The medicinal approach to treating migraines is effective for the short term and is accompanied by serious long term side effects⁴. The studies conducted on the therapeutic effects of Acupuncture for Migraine have mainly focused on the prophylactic intervention of headache rather than concentrating on the treatment of acute cases. Those that have been conducted were either done on a small scale or compared acupuncture with traditional medicinal treatment. This review compiles literature to demonstrate the efficacy of Acupuncture for short and long term prophylactic and acute treatment of Migraine. According to a survey conducted by Lifting ‘The Burden’, an international campaign against headache, the prevalence of migraine was 9.3% for a year⁵. It is one of the major burdens in the United States, costing 6.5 to 17 billion US Dollars each year^{6, 7}.

The pharmacological treatment for migraines includes Non-steroidal Anti-inflammatory Drugs (NSAIDs), Ergotamines, Triptans, and Antiepileptics. Nonetheless, drug therapy comes with its own untoward side effects⁸. These side effects include nausea, vomiting, tiredness, and insomnia, leading to patient incompliance⁹. Thus, patients are now looking for alternative treatments that are long-lasting and short of adverse effects. Acupuncture has been one of the vital techniques in Traditional Chinese Medicine. It is commonly employed as a therapy for migraine in clinical practice. Acupuncture is also reported to be a widely used accompanying treatment globally¹⁰.

Acupuncture therapy originated in China more than 3000 years ago and from there it spread to American and European countries, between the 16th and 19^th centuries. It was in the 18^th century when the first research related to Acupuncture was conducted and has ever since developed rapidly. History shows that general practitioners put great efforts to perform acupuncture within their clinical setting and scientists paid attention to what characteristics acupoints and meridians possessed. As of today, scientists have been successful in analyzing the true value of acupuncture therapy as well as its fundamental physiological and biological mechanisms have been evaluated¹¹.

Acupuncture is the process that incorporates the use of fine needles insertion on specific points on the skin to cause stimulation¹². Acupuncture treatment roots to the Traditional Chinese Medicine (TCM) and is based on Acupuncture points which correspond to ‘physiological and anatomical features such as peripheral nerve junctions’, believed to be the trigger points. However, there are several variants of methods of acupuncture therapy. The TCM believes the meridian to be a vital component of acupuncture treatment. It is along the meridian that the feeling of paresthesia, numbness, or distention is radiated from the needling site, referred to as de-qi (pronounced duh chee)¹³.

Sham acupuncture (SA) is a type of acupuncture used as placebo acupuncture (PA) on control groups for research. This procedure is done as one of the following.

• Away from the points on the skin established for acupuncture by the TCM
• Without stimulating de-qi sensations
• By making use of a non-penetrating technique^{14, 15}

Acupuncture points for Migraine

Research has shown that what’s responsible for the effectiveness of acupuncture are the physiological features of the skin caused by acupuncture needle insertion at specific points such as tenderness and palpable coagulations. These sensations are partially responsible for the stimulation of pain receptors and their corresponding fibers. Performing acupuncture therapy causes the induction of an explicit sensation referred to as de-qi. Although the de-qi sensation is thought to be vital for a successful acupuncture treatment, the specific fibers of de-qi have not been discovered. It has been found that injecting local anesthesia to L14 acupuncture points entirely halts de-qi sensitization responsible for bringing about the acupuncture effects. Standard Chinese textbooks also support the idea of tenderness being a physiological characteristic of acupuncture points. According to these textbooks, the point where the inserted needle strikes is called as the ah-shi point induces a perceptible response to pain¹².

Mechanism of Action of Acupuncture

A 2015 study stated that Peking University began scientific research about the mechanism of action of acupuncture therapy in the 1950s. According to the study, there is a role of chemical substances in the palliative response of acupuncture, and proposed that a duration of 15 to 20 minutes is required for the initiation of its analgesic effect. Electro-Acupuncture Analgesia (EAA) was reported to be disaffected by naloxone which is a potent opioid receptor antagonist. The study also established that Endogenous Opioid Peptides (EOPs) played an important role in the effectiveness of acupuncture therapy and their levels were found to elevate in plasma or cerebrospinal fluid (CSF) after EAA. Gentle handling of the needle enables immediate pain relief at acupuncture centers. Diffuse Noxious Inhibitory Controls (DNIC) is one possible mechanism for this immediate effect. DNIC is considered to alleviate pain with the application of a deleterious stimulus without any induction time by suppressing the transmission of signals in the dorsal horn of the spinal cord and/or trigeminal caudalis neurons. The action of DNIC needs the stimulation of afferent fibers (A-delta and C) found throughout the skin¹².

Several other studies have investigated Acupuncture’s action mechanisms for the management of pain. These studies also established that the levels of following endogenous chemical substances play a substantial role in pain relief by acupuncture treatment.

• Opioid Peptides
• Serotonin
• Norepinephrine

This mechanism of action comes into play by

• Inhibition of inflammatory cytokines,
• Inhibition of visceral nociceptors
• Activation of CNS¹⁶

Treatment of pain through Acupuncture has been a common practice in German countries¹⁷. It is also earning wide acceptance in the Western world as an alternative therapy not only for migraine but also for other pain conditions¹⁸.

 

 

Literature Review

Western Medicine Perspective

Acupuncture in the Western medicine involves the use of fine-needle insertion in the skin – an adaptation of TCM incorporating the concepts of evidence-based medicine as well as the existing understanding of physiology, anatomy, and pathology. The assimilation of acupuncture into the Western medicine is not straightforward because of the theoretical variations of concepts between the two approaches. Although acupuncture has developed from TCM, the Western medicinal practitioners do not hold on to its principles including the flow of qi and Yin/Yang. Acupuncture is considered to be a component of traditional medicine instead of being an entirely separate category of alternative medicine. It is considered to work by stimulating the nervous system, involving various CNS modalities like local antidromic axon reflexes, segmental and extra segmental neuromodulation, etc. Acupuncture, however, should be given a greater status as The World Health Organization (WHO), values acupuncture as an effective treatment modality and recommends it for inclusion into the National Health Systems (NHS). This inclusion would help lessen the cost burden of some high-priced traditional treatments. Furthermore, a 2017 study, based on perceptions of health professionals, showed that acupuncture is believed to be a valuable modality to curb the rising levels of chronic and degenerative diseases. Instead of actual integration with TCM-based acupuncture, acupuncture in Western medicine is performed in the conventional healthcare system as part of the primary care practice and paradigm19. However, whether there is a lack of physician training and knowledge about acupuncture, acting as a key hindrance in its adequate integration in the Western medicine has not been clearly identified. The results were based on only 27 in-depth interviews and only included the healthcare workers who were ‘trained in acupuncture based on the World Health Organisation recommendations’, exclusive of the critiques, thus lacked quality.

Migraine is said to be one of the most common causes of recurring headaches. More than 20% of women and 10% of men suffer from migraines at some point in life with about 1% of the population suffering from chronic migraines worldwide. A 2016 systematic analysis for the Global Burden of Disease shows that there is a higher prevalence of migraine per 100,000 population, ranging from 17000-21000 in Eastern Mediterranean countries, the Persian Gulf, and the Balkan Peninsula²⁰ as shown in figure 1. Even though the predisposition to experience migraine is based on hereditary, internal, or external factors may incite individual episodes. The word migraine is derived from the Greek word hemicranias which means ‘half of the head’. The root word corresponds to a prominent symptom of the condition which is a unilateral headache. However, pain may also be felt on both sides, and front or back of the head, and in very rare cases, in the face, and the body (‘migrainous corpalgia’). The following are the typical symptoms that might be felt during a migraine attack.

1. Moderate to severe headache throbbing in nature
2. Pain aggravates on movement or activity such as climbing stairs
3. Unilateral pain most commonly, but frontotemporal and ocular regions may also be affected and pain might affect any area in the head or neck
4. Gradual escalation of pain over 1–2 hours of time, making progress towards the  posterior region while becoming diffuse
5. Time duration of pain 4 to 72 hours
6. Nausea and vomiting accompanied by food intolerance, light-headedness, and anorexia
7. Irritability to sound, light, and smell
8. Lack of appetite and disturbed bowel function¹

Chronic migraine (headaches lasting for minimum 15 days in a month) has over the years spurred an escalating concern in the understanding of its epidemiology, pathophysiology and treatment of this condition²¹. The International Classification of Headache Disorders (ICHD) laid down a complete classification of migraine in 2013. The major types of migraine headaches are as follows:

• Plausible migraine without aura
• Migraine without aura previously known as Common Migraine)
• Migraine with aura previously known as Classic Migraine
• Plausible migraine with aura
• Chronic migraine
• Chronic migraine due to excessive use of analgesics
• Periodic syndromes possibly not associated with migraine in childhood
• Complications of migraine
• The migrainous disease not satisfying the aforementioned criteria

Accurate diagnosis of migraine has been described by the International Headache Society to be episodes of a minimum of 5 attacks that meet the subsequent criteria. A study has described sequential steps to a proper diagnosis of migraine which includes:

1. Each episode of headache should last for 4 to 72 hours with or without treatment²².
2. The headache should meet two or more of the following traits
   1. Unilateral pain
   2. Throbbing nature
   3. Moderate to severe intensity
   4. Intensification by routine physical activity
3. Throughout the headache attack, one of the following symptoms should be felt
   1. Nausea with or without vomiting
   2. Photophobia and/or phonophobia²³

The treatment modalities for migraines in conventional Western medicine include Lifestyle modification, medication for acute headache treatment, and Prophylactic care. Lifestyle modifications include avoidance of triggers, losing weight, reducing stress, taking enough sleep, etc²⁴.

Acute pharmacotherapy for migraine includes Analgesics (Ibuprofen, Aspirin, Naproxen), Triptans (Sumatriptan, Almotriptan, Frovatriptan, etc.), and Combination drugs (Sumatriptan and Naproxen) while the preventive therapy comprises of β-Blockers (Propranolol, Metoprolol), Angiotensin Blockers (Candesartan) and Tricyclic Antidepressants (Amitriptyline, Nortriptyline, Dosulepin) as the first line treatment^1. Other drugs used to treat migraines include opioids (butorphanol nasal spray) and antiepileptics. Although the results of these medications are promising, they come with their own sets of side effects, especially when taken for the long term. When analgesics are taken for long, they lead to medicine-overuse headache (MOH), while there is also a possibility of developing ulcers and bleeding in the gastrointestinal tract. Although triptans can be relieving as they block the pain pathways to the brain, they can cause dizziness, tingling, flushing, chest tightness and are not advisable for severely hypertensive people, who are at risk of heart attack or stroke. They are also contraindicated for patients who have a history of suggestive coronary, peripheral, and cerebrovascular diseases²⁵. Blood pressure-reducing drugs; β-Blockers are effective for the prevention of migraine with aura, however, they cause nausea, fatigue, dizziness, depression, insomnia, and reduced blood pressure. Angiotensin Blockers lead to fainting, fatigue, vomiting, upset stomach, hyperkalemia, tissue swelling as well as the risk of liver and kidney failure. Likewise, Tricyclics also cause adverse effects including sleepiness, weight gain, dry mouth as well as reduced libido. Medications used for the management of migraine and their side effects are summarized in Table 2. The use of these medications is still under debate due to their side effects and the efficacy of headache management remains a potentially movable specialty and a challenge for physicians and neurologists. Therefore, a great number of migraineurs are migrating to complementary and alternative medicine (CAM)²⁶. This information is substantial because it comes from a 2018 high-quality RCTs Systematic Review and Meta-analysis

Conversely, it has been established that the performing acupuncture for migraine at points originating from meridians of the liver and gallbladder is not only safe and effective but is also shows consistent effects in the long-term subsequent to employing one session per day for 5 days and a gap of 2 days, continued for 4 weeks. However, hefty randomized controlled trials of high quality are required for the effectiveness of acupuncture for migraine. Sant’Ana suggested that individual follow-up records can be more reliable to evaluate the progress of treatment, keeping the patients as their own control²⁷. Similarly, it has been proposed that acupuncture is either equally effective or more successful than preventive pharmacotherapy with minimal side effects, and suggested that acupuncture should be one of the treatment options for those who show a willingness to use it as a therapy.

A Clinical Pilot study was carried out by Ahn C-B, comparing Traditional and Combined Acupuncture for Headache, Retroauricular pain in Facial Palsy, and Trigeminal Neuralgia. Combined Acupuncture (CA) included traditional acupuncture (TA) and ear acupuncture (EA). The findings reported that acupuncture helps to alleviate headaches with no significant difference (p = 0.968) between the various types of acupuncture techniques applied. However, the headache was found to be the disorder among others, that was most significantly relieved (p = 0.018)²⁸. Likewise, migraine headache is to be managed with a comprehensive approach. The study talked about various other trials focusing on headaches and migraines. One study reported acupuncture to be superior to sham acupuncture as well as to pharmacotherapy in reducing the severity, response rate, and frequency of headache. Another study explained that laser acupuncture also had promising results for treating chronic tension-type headache. However, the conduction of large-scale studies was needed. Li et al. conducted 20 sessions per patient over a span of 20 weeks, and suggested that the efficacy of acupuncture for migraine is either by means of ‘acupoints of different meridians or different acupoints of one meridian’. On the contrary, Linde et al reported that acupuncture was no more valuable than sham acupuncture in alleviating migraine headaches even though both procedures were more effective when compared to the waiting list controls when tested for 12 sessions for 8 weeks. Molsberger et al. ensured 10 acupuncture treatments per patient for 6 weeks and assured lofty external soundness of results for migraine and tension-type headache in the German Acupuncture Trials (GAT). In the milieu of Western medicine, these results helped establish the worth of Chinese acupuncture for the management of the said headaches. Another study supported the importance of acupuncture for the management of ‘idiopathic headaches’, however, claimed inadequacy of high-quality and quantity of evidence. Thereby, suggesting a dire need for well-structured, large-scale research to evaluate the efficacy of results and worth of acupuncture under practical circumstances.

Many countries employ the use of acupuncture to avail its benefits in increasing response rates and reducing the economical burden of migraines. The governmental health insurance companies in Austria and Germany offer acupuncture therapy for chronic pain management. It is also occasionally accessible along with physiotherapy departments in the United Kingdom National Health Service. 77% of clinics In Germany are devoted to using acupuncture for pain management. 20% of hospitals in the United States perform acupuncture as a complementary treatment among others. 7.4% of the Spanish population recognize the benevolent characteristics of acupuncture and utilize this procedure under physician-supervision due to a number of reasons. These include its safety of use, the property of being free of adverse effects, and its prospective use alongside traditional medical treatments. The European Union also recommends conduction of further studies on acupuncture as per their physicians’ suggestions. The health providers in the Western world including doctors, nurses, physiotherapists as well as midwives believe that acupuncture is a valuable adjunct therapy that immensely supplements conventional medicine. There is a need, however, to further advance researchers’ understanding of acupuncture for facilitating recommendations and dialogue between both medicines¹⁹.

 

Traditional Chinese Medicine Perspective

TCM is the standard Chinese medicine practiced prior to the Chinese Revolution. It has its foundation on various early ideologies which include 1) the Daoist belief; ‘the human body is a diminutive form of the universe’; 2) Qi; the vital energy that flows through the body and executes a multitude of functions for the maintenance of health; 3) Yin/Yang – synchronization of contrasting and balancing forces which maintain health; 4) the Five Element Theory. According to TCM, an obstruction or discrepancy of qi leads to chronic pain, and that its aim is to achieve balance in flow. The Yin/Yang hypothesis illustrates the Yin or Yang nature of health, which includes 1) its location (internal or external); 2) temperature (cold or hot); 3) magnitude (scarce or surplus). The Yin/Yang describes polarity with the idea that an attribute is unable to co-exist alone in the absence of the other. The Five Element Theory characteristically symbolizes the phases of human life and elucidates the performance of the human body. In order to understand the ideology of TCM, it is imperative to have knowledge of the aforementioned notions²⁹.

The fundamental nature of TCM is considered to be one of the most sophisticated and practiced remedies globally. It comprises an enormous system that is full of realistic and convenient medical equipment and authentic practice that has been steadily integrated into contemporary medicine. The foundation of TCM is based on the knowledge that has the capacity to direct future healthcare advancement. Yet, its simplicity and versatility allow it to adapt and blend into any type of culture and time. The framework of TCM is made up of three components: 1) the component that complements the most recent medicine; 2) the component that is impulsively ahead of modern medicine; 3) the component that needs further analysis and assessment to be adopted or discarded by modern medicine. The Western medicine was first introduced in China in the 16th century, however, it had little impact as it was not a common practice in the healthcare system. The practice of traditional Chinese medicine was the principal entity practiced in China until the Opium War, after which the practice of Western medicine actually began³⁰.

Migraine has been found to cause a great socioeconomic burden to a population of more than 1.3 million in China with the approximated cost of CNY 672.7 billion and a gross domestic product (GDP) of 2.24% for primary headache³¹. According to the TCM hypothesis, migraine is categorized as an external attack or an internal disturbance. The qi and blood flow from different body channels move towards the head. Stagnation of qi and blood is often present with migraines. The short-duration excess kind of migraine occurs due to external factors such as wind, heat, cold, or dampness, the wind being the commonest factor. Chronic migraine occurs due to internal disruption related to the liver, spleen, and kidneys. Manifestations of the excess of liver yang coupled with a deficiency in these organs lead to chronic migraines with the patterns of deficiency presenting with noticeable excesses like phlegm and blood stasis. Changes in weather, emotions, dietary habits, sexual activity, posture, menstruation, and hypertension are the other reasons involved. The buildup of damp phlegm along with the consumption of fatty or sweet edibles or dairy products elicits migraine, while alcoholism and eating pungent foods can aggravate stomach or liver fire. An exacerbating headache with pressure occurs because of an excess state³².

Western medicine takes migraine as a condition of repetitive headaches with indefinite reasons and the typical symptoms are pulsating, moderate to severe, unilateral headaches that intensify with activity, accompanied by other symptoms including nausea, vomiting, and irritability to light or sound. These symptoms are normally considered to be based on neurovascular dysfunctional grounds and are generally elicited by stress, tiredness, insomnia, weather changes, and menstruation³³. TCM considers migraine to be caused primarily by ‘wind and fire invasion’ that results in hindrance in meridian and disturbance of the flow of q and blood in the head. Moreover, it is believed that liver dysfunction and its relevant meridian have an important role in the development of migraine. Thus, the main aim of TCM in the treatment of migraines is to; 1) Unblock the meridians; 2) Eliminate the pathogens; 3) Calm the liver and it is recommended that the treatment plan should be devised as per individual disharmony pattern. Pain in different parts of the head explains the type of disharmony involved. The regions of pain and their pertinent causes are discussed below.

• Supra-orbital pain – involves unilateral or bilateral pain above the eyebrows that may spread towards the forehead. According to the TCM perspective, this location of pain occurs due to the incursion of wind-heat perpetrators or stasis alongside wind perpetrators. Furthermore, disturbance in the stomach and gallbladder meridians have an important part as causative factors of migraine.
• Distention in the head – one of the common manifestations includes distention, felt on the head that feels like splitting in severe cases. TCM considers this feeling of distention of the head to be caused by profuse qi and blood flow towards the head leading to their confined stagnation, disturbing the orifices in the head.
• Feeling of heaviness in the head – if the headache feels like a weight over the head, TCM considers it to be due to dampness as the pathogens of dampness are intense and have turbid characteristics, hence, disturbing the flow of qi and resulting in the slow movement of the meridians. Similarly, other stagnations including those caused by a dysfunctional liver and disturbed yang also lead to a heavy head feeling³⁴.

Migraine headaches may also occur during or around menstruation in women and may be unilateral or bilateral. Study shows that more than 50% of women migraineurs suffer from menstrual-related migraine (MRM)³⁵. This condition occurs due to disturbance in female hormones and is accompanied by nausea, vomiting, lack of appetite, and weakness.TCM considers excessive flushing of qi and blood in the uterus leading to menstruation while reducing the flow of qi and blood in the head. Thereby, it is established that the dysfunction or blockage of head orifices lead to headache during menstruation especially in women who already have hyperactive liver, yin disturbances, and qi and blood flow disruptions. TCM, thus, holds to treat menstrual headaches by regulating qi and blood flow to clear the meridians. Similarly, headaches during pregnancy occur due to changes in hormone levels and increased blood circulation. It has been hypothesized that headache substantially improves or eliminated during the second and third trimesters, due to a decrease in hormonal instability³⁶. As the blood flow to the uterus increases to supply nutrition to the fetus, the disharmony occurs due to a deficient volume of blood at other locations including the head – Yin/Yang disharmony.

 

Acupuncture

A concise outline of Deqi response is discussed along with the existing collection of studies with respect to its association with the pain-relieving and other valuable properties of acupuncture. Deqi is considered to bring about its effect through slow conducting nerve fibers which enhance the dull component of pain that makes acupuncture effective. The acupuncture effect is brought about partly by the assimilation of these dull signals in the CNS which also modulates other sensory inputs. As of the versatile nature of sensations brought about by Deqi and acupuncture, researchers have endeavored to explore the types of nerve fibers involved. However, it is now established in general that there are several types of nerve fibers involved in Deqi including both high conducting myelinated Aβ fibers and slow conducting C fibers³⁷.

Quantification of Deqi and presenting the results of acupuncture in a consistent and methodical way is yet not straightforward. Despite the development of several questionnaires dealing with this subject, their adequate utilization other than small studies has not been done. Thus, the true mechanism of deqi relative to analgesia is still a chief concern that brings about challenges for researchers investigating acupuncture. Novel technologies like MRI are being employed in studies to understand these reservations. Studies have found that for acute pain, low and high-frequency electroacupuncture (EA) reduces thermal pain employing μ, δ, and κ opioid receptors while for persistent pain both high and low frequencies reduce mechanical, thermal, and impulsive pain by stimulation of μ and δ opioid receptors. A frequency of 10 Hz EA brings about extended inhibition of inflammatory pain as compared to 100 Hz. Even though there is some understanding of the relationship of Deqi with analgesia among researchers, large-scale, uniform and standardized scientific studies are needed to validate the necessity of achieving Deqi³⁸.

Manual acupuncture and Electroacupuncture are the types of acupuncture therapies utilized to treat disorders in the Eastern for decades. Although the merits of acupuncture are becoming more evident with time, its acceptance in the Western world remains controversial. The gradual progress of acceptability and vague understanding of its mechanism of action has led to its slow acceptance in Western medicine. Acupuncture’s mode of delivery and subjective characteristics has rooted the controversy around it. One of its vital elements is called Deqi, which is the stimulation of ‘qi or vital energy’ within specific meridians. Deqi is thought to be an important factor to accomplish the desired remedial effects of acupuncture therapy. The sensations felt during the acupuncture procedure include tingling sensation due to needle insertion, numbness, tenderness, and dull pain. Upon analyzing the Deqi response to acupuncture therapy at several acupoints with the help of functional magnetic resonance imaging (MRI), it was found that the commonest sensations associated with Deqi are tenderness, aches, and pressure after numbness, tingling, dull pain, warmth, coolness, heaviness, and fullness. Deqi is considered an essential part of analgesia, by practitioners of acupuncture. Interestingly, it has been found that if local anesthetics are injected before acupuncture in the intramuscular tissue, both the Deqi response and analgesia are eliminated. A study described that the type II afferent nerve fibers, innervating the skin and muscles are employed in the analgesic effect brought about by acupuncture³⁹. It is important to characterize how pain response is brought about after acupuncture in order to understand the role of Deqi. When a noxious stimulus is applied, a sharp sensation is felt which precedes the dull sensation – called ‘second pain’. However, in the Deqi response, the dull component comes followed by sharp pain. Needle insertion in acupuncture stimulates deeper nerve fibers in contrast to the superficial nerve fibers that carry painful stimuli like heat.

One of the keys proves to Western medicine about the scientific authenticity of pain control by acupuncture was the successful analgesia brought about for surgeries in China. In such a scenario, the analgesic effect could not be regarded as a placebo effect. This idea is interesting because, in Western medicine, pain control is a critical and exasperating component that needs consistent investigation.  NSAIDs are not very effective for surgical anesthesia while narcotics have addictive potential and other than these medications there is limited certainty pertaining to pain control in surgery. Hence, if the analgesic effect of acupuncture is evident in surgical pain control then there could be a high potential for its remarkable efficacy in ordinary pain conditions like headaches. Previously, acupuncture was considered to act as a powerful placebo or a type of hypnosis. Early on, the Chinese practitioners used acupuncture for treating animals, and scientists utilized animal models to collect data not practically obtainable from human subjects. However, authoritative scientific proof of acupuncture not merely being hypnosis was accounted for by Gold-stein and Hilgard at Stanford in 1975. According to them, naloxone hydrochloride, an opiate receptor antagonist in the brain, could inhibit the analgesic activity of opiates and acupuncture but not the analgesia that was elicited by hypnosis. The gate theory of pain control, consistent with the analgesic effects of acupuncture was proposed in 1965 by Melzack and Patrick. The theory stated that the transmission of sensations from the skin occurs through different groups of neurons which consist of cell processes distributed in the skin throughout the superficial and deeper tissues.  Various different types of nerve fibers are employed in the transmission of signals through different categories of neurons. Transmission of touch and sharp pain sensations occurs through neurons with myelinated A-delta fibers, whereas pain in deeper structures passes through unmyelinated C fibers. While it is considered that intense, incapacitating, and chronic pains are transmitted by C fibers, both kinds of impulses are modulated by the dorsal horns of the spinal cord. The gate theory included the recently identified mechanism of ‘presynaptic control of synaptic transmission’ from superficial and deep afferents which affect the balance between the sensory inputs. According to Melzack, increasing the rate of transmission in A-delta fibers would reduce the transmission rate of the C fibers transmitting pain. The resulting effect would be a reduction in the number of noxious impulses reaching the brain, thus, “gating” the pain signals⁴⁰. Most of the people instinctively rub our skin when struck by a hard object such as a hammer, and also tend to rub the head of a child who falls and hits the ground. These responses are consistent with the gate theory of pain control. Similarly, the superficial needling stimulation in acupuncture therapy brings about the same response, interrupting the painful C-fiber transmission, thereby, corresponding to the analgesic effect. Furthermore, this concept also explains the effectiveness of acupuncture therapy, in which the acupoints are distant from the definite pain site. Inhibition of pain occurs as the transmission level of the site of pain and the acupoints in the spinal cord is the same. Numerous acupoints for analgesia are distributed in the face, arms, and legs, and represent large areas in the thalamus as well as the sensory area in the cerebral cortex. There is also a likelihood that comparable gate-like mechanisms of pain signal control occur in these higher regions as well.

Conversely, the gate theory alone cannot be explanatory of the mechanisms of signal transmission of one neuron altering those of other neurons. According to studies of the past, it was reported that there is an important role played by the neurochemicals such as endorphins and substance P, along the synapses for the modulation of neuronal signal transmissions within the spinal cord and CNS. One such strong category of polypeptides is the endorphins, vital for the transmission of pain signals to the brain. The identification of these endorphins including fJ-Endorphin, enkephalin, and dynorphins, took place in the 1970s. 3-Endorphins are the type of opiate receptors whose actions can be inhibited by an antagonist, naloxone hydrochloride, eliminating the effects of acupuncture anesthesia. It was prior to the discovery of endorphins that the Chinese researchers claimed that animal to animal transfer of acupuncture’s analgesic effect was possible through serum transfusion. They deduced that it was possible due to the ‘soluble pain-suppressing substance’ produced through acupuncture stimulation. Research has supported this idea detailing that endorphins are produced by acupuncture; however, varying frequencies of electrical needle stimulation will result in the production of different types of endorphins. Studies have supported this idea reporting that low frequency (2 Hz) EA on uninjured rats triggered endorphin/endomorphin and enkephalin, whereas high-frequency EA of 100 Hz stimulated dynorphin to inhibit nociception. This finding paves way for further research on the potential of acupuncture to produce prolonged analgesia for surgeries ⁴¹.

 

Acupuncture and TCM

The TCM aims to facilitate patients to accomplish consistent health. For this purpose, six novel curative techniques are formulated in TCM, which include 1) Acupuncture; 2) Moxibustion; 3) Tui Na massage; 4) Cupping/Scraping; 5) Chinese Herbs; 6) TCM Nutrition. This paper, however, sheds light on the process of Acupuncture and its effectiveness for migraine headaches. Out of all the procedures, Acupuncture is the most commonly practiced part of TCM. Acupuncture is one of the oldest and most commonly used complementary and alternative medical treatments in the world. Acupuncture was found in China from 1600-1100 B.C during the Shang Dynasty but it was not until 1971 that it became popular in the Western world. ¹ TCM involves the use of as many as 2,000 acupuncture points used for various ailments in the human body. These points are connected by 12 key meridians. Qi is accomplished through these meridians, from the body surface to the related internal organs. The concept of Yin in acupuncture involves the parasympathetic nervous system Yang involves the sympathetic nervous system. Acupuncture is considered to maintain the balance between Yin and Yang. This equilibrium favors the normal flow of Qi related to neural transmission in the human body and works to reinstate psychological and physical health to the mind and body²⁹.

The practitioners of acupuncture consider the pathologies of the body as a whole. Several different acupoints and manipulations are used for different body conditions. The choice of acupoints has an effect on several disorders to incite the body to treat disorders by modulating the course of pathology and improving health. This regulation is achieved by the integration of the CNS and include:

• Cortex recombination
• Neural plasticity
• Release of various neurotransmitters and hormones

The foundation of acupuncture is considered to revolve around gene expression. Likewise, acupuncture anesthesia is a way to avert surgical pain and alleviate physiological dysfunction. It is particularly appropriate for patients allergic to narcotic drugs. Shanghai No. 1 People’s Hospital has utilized acupuncture analgesia instead of narcotic drugs to carry out tonsillectomies since 1958. This use had paved the way since then, for acupuncture anesthesia to be used for general practice rather than just selected applications. Research and scientific evaluation has found acupuncture to be clinically effective in acupuncture anesthesia in various surgeries including thyroid surgery, craniocerebral operation, surgery of posterior cranial fossa, cesarean section, tubal ligation, tooth extraction, etc. However, acupuncture’s anesthetic efficacy has not been proved in perineal surgery and limb surgery³⁰.

Efficacy of acupuncture for migraine

A multicenter, single-blinded RCT investigated the effectiveness of acupuncture for acute migraine episodes in comparison with sham acupuncture. 150 human subjects were allocated to verum or sham acupuncture, over a period of 2 years from 2007 to 2009 with a 1:1 ratio. Each patient was given a verum (traditional) or sham (placebo) acupuncture therapy during a migraine attack, with medications allowed if the pain persisted two hours after acupuncture treatment. The results were obtained using the visual analog scale (VAS) scores for pain, from 0 (no pain) to 10 (worst pain ever). The study showed that the average VAS scores about 24 hours post-treatment were reduced from approximately 5.7 ± 1.4 to 3.3 ± 2.5 and  5.4 ± 1.3 to 4.7 ± 2.4 for verum and sham acupuncture groups respectively. There was a significant difference between the effectiveness of outcomes between the two groups (P = 0.001). Thus, suggesting that the ‘verum acupuncture group was superior to sham acupuncture group’ for pain relief and leads to a reduction in the use of acute traditional medication⁴².

On the contrary, a 2020 literature review evaluated the effectiveness of acupuncture on the rate and severity of menstrual in clinical practice concluded that there was insufficient convincing evidence to sustain the utilization of acupuncture for the treatment of menstrual migraines.Thus, held that acupuncture cannot be recommended for menstrual migraines before further evidence is produced. However, there were many limitations and glitches in the study. First, out of the 428 publication records, 414 were excluded leaving it with only 13 completed and 1 ongoing trial. Among the 13 completed studies included, not a single study had a low risk of bias; three had an unclear risk of bias while 10 were associated with a high risk of bias. A total of 11 studies applied manual acupuncture, and Deqi was accomplished by all of these 11 studies. Furthermore, only a few of these 11 studies successfully reported the depth of insertion of needles and the number of needle insertions per subject in a session, with most studies not reporting the setting and context of treatment and the qualification of the acupuncturists. Only five out of the 9 studies which compared acupuncture with analgesic medications scored the average headache intensity by VAS. Second, the Pooled analysis of the review itself, suggested that there was a significant reduction in the severity of headache immediately after the acupuncture treatment, as compared to analgesic medications (p<0.00001), rendering it inconsistent with the conclusion. Two studies evaluated that the headache persisted with the use of ibuprofen and flunarizine and found better effects with acupuncture than with medications after 3 and 6 months post-treatment. The review also conclusively discussed that acupuncture was safe and only had minor adverse effects which did not require any further treatment, unlike the analgesic medications, referencing a systematic review by Linde et al⁴³ which showed that acupuncture as an adjunct to symptomatic therapy of migraine decreases the rate of occurrence of a headache. It also stated that there is evidence showing that acupuncture is more efficient than sham control and has comparable effects as preventive medications for the prophylaxis of migraine attacks. Third, solid acupoints for the treatment of migraine were not identified. Text mining was used to identify the most frequently used acupoints as Taichong (LR3), Shuaigu (GB8), Sanyinjiao (SP6), Fengchi (GB20), Baihui (DU20), Hegu (LI4) , Taiyang (EX-HN5), and Zusanli (ST36). However, the study demonstrated that these points were not sufficiently strong to modify MM symptoms for an experiment and only a few studies opted for acupoints that restored the functionality of the reproductive organ. It was also suggested that precise grouping of acupoints could be done by adding more acupoints corresponding to reproductive function, such as on the liver or kidney meridians. Fourth, each study had a sample size that brought bias to meta-analyses because of sampling error. Furthermore, a funnel plot test was not performed to identify the publication bias due to a deficient number of included trials. On top of that, any missing inaccessible datum was replaced with values, treating them as observed records. The quality of evidence was generally low. All included studies were underpowered⁴⁴.

Another study evaluates the value and safety of manual acupuncture as a preventive modality of recurrent migraines. Fifty frequent migraineurs were selected randomly and were given a total of 16 treatment sessions over 20 weeks. This was done

• two times per week for four weeks (8 sessions)
• then once a week for another four weeks (4 sessions)
• followed by once every two weeks for four weeks (2 sessions)
• then once a month for two months (2 sessions)

The selection of acupoints was based on the Standard Acupuncture Nomenclature by the World Health Organization. At the end of the treatment, the RA group showed significantly fewer migraine days as compared to the SA group (RA: 5.2 ± 5.0, SA: 10.1 ± 7.1; p=0.008). The severity of migraine was found to decrease in the RA group (2.18 ± 1.05) more than the SA (2.93 ± 0.61, p=0.004). More responders with RA (19) compared to the 7 with SA, and increased pressure pain thresholds. These group differences remained the same at the three-month follow-up, but not by the end of the one-year follow-up. Blinding was successfully accomplished with no serious effects reported. Thus, the results showed that manual acupuncture was safe and effective for short-term treatment of recurrent migraine attacks in adults. However, large trials and long term studies were recommended⁴⁵.

In one of the latest studies, Xu S et al also conducted an assessment of the efficacy of acupuncture as a preventive treatment for episodic migraine without aura in 7 hospitals in China, from June 2016 to November 2018. The research was a multicentre, randomized, controlled clinical trial having 150 blinded participants, a statistician, and outcome assessment. The subjects were divided into three groups. To group 1, 20 sessions of manual acupuncture (MA) were conducted involving true acupuncture points along with the usual care. To the second group, 20 sessions of non-penetrating sham acupuncture (SA) were done at ‘heterosegmental non-acupuncture points’ with usual care, and group 3 got the usual care alone over 8 weeks. Out of 150 randomized patients with an average age of 36.5 years and 123 (82%) women, 147 were utilized in the full analysis set. Manual acupuncture showed a significant decrease in migraine days from weeks 13 to 20 as compared to sham acupuncture as well as a significantly greater decline in migraine attacks from weeks 17 to 20. At weeks 13 to 16, the mean number of migraine days reduced to 3.5 for MA as compared to 2.4 for SA (P=0.005) and at weeks 17 to 20, 3.9 for manual versus 2.2 for sham (P<0.001). The decline in the mean number of migraine attacks was 2.3 for MA compared to 1.6 for SA at weeks 17 to 20 (P<0.001). Furthermore, there were no occurrences of severe adverse events. These findings concluded that manual acupuncture was superior to both sham acupuncture and usual care as a preventive treatment modality of episodic migraine without aura. Thus, manual acupuncture is suggested to be considered in future guidelines as the recommended option for patients who are either non-compliant to use prophylactic drugs or when these drugs are not effective⁴⁶.

Another 2017 study included randomized trials of acupuncture needling in comparison to 1) sham acupuncture or 2) no acupuncture control for osteoarthritis, chronic headache, nonspecific musculoskeletal pain, or shoulder pain. Only the trials having explicitly determined allocation concealment were included. Unrefined data sourced from study authors were fed into an ‘individual patient data meta-analysis’ with the primary outcome measures being pain and function. Additionally, out of the data obtained for 20,827 patients from 39 trials, 13 trials were included. Acupuncture was found to be superior to both sham and no acupuncture control for all pain conditions (all P < .001). It was also reported that there is clear evidence for acupuncture effects to last over time with only a small reduction (about 15%) in treatment effect after 1 year. Thereby, it was concluded that acupuncture is efficacious for treating chronic pain, with treatment effects continuing over time⁴⁷.

According to a case report on a patient who acquired Postdural puncture headache (PDPH) after epidural anesthesia, it was found that the patient was unresponsive to traditional pharmacological therapies such as intravenous caffeine and an epidural blood patch but was successfully relieved by adjunct acupuncture. The patient was treated for nausea on the first and second postoperative days and developed headache on the third postoperative day in the occiput and bilateral eyes coupled with photosensitivity and nausea. The patient reported a pain of level 5 to 6 on the pain numerical rating scale (PNRS) (0 being no pain and 10 being worst imaginable pain). Due to the severity of his symptoms, he couldn’t ambulate or accept a diet. The fourth postoperative day (POD) showed a worsening of his headache to a PNRS of 10 which was not eased by sumatriptan or cyclobenzaprine. First acupuncture therapy was performed as an adjunct on the fourth POD reporting improvement in headache over the next couple of hours with a decrease in PNRS to 7 over about 3 hours. On the fifth POD, the patient accepted a second acupuncture therapy and reported a decrease in PNRS from 8 to 5 within 30 minutes. The sixth POD, the patient could ambulate, tolerate a regular diet and accomplished sufficient pain control with oral pain killers while the headache PNRS decreased to 2/10 before he was discharged⁴⁸. This is in coherence with another single case report which showed that a 32-year-old Ethiopian-American woman who had a 10-year history of migraine was treated with acupuncture and other Chinese herbal medicines over 2 months experienced pain relief lasting several months. She described her pain score to be 10 out of 10, accompanied with nausea, vomiting, photophobia, visual disturbances etc. The patient received a traditional acupuncture session per week to achieve de qi for 6 weeks at relevant acupoints, along with dietary modification and Chinese herbal treatment. After the first week of therapy, the patient reported her pain score to reduce to 5 out of 10, milder pain of shorter duration in the second week. The pain intensity further reduced to 3 out of 10 by the 5^th week. After the 6-week treatment, the patient returned on follow up after 8 months and reported that acupuncture helped her get rid of acute pain while maintenance of the recommended diet and herbs has allowed her to sustain relief from migraine³²

There is accumulating evidence showing that acupuncture improves migraine outcomes. A study used proton magnetic resonance spectroscopy imaging to evaluate the biochemical levels before and after acupuncture treatment. Subjects (n=45) included those who had confirmed diagnosis of migraine without aura, cervicogenic headache, and healthy controls. Subjects diagnosed with two types of headaches were given verum acupuncture on acupoints targeting migraine without aura only, whereas sham acupuncture was given to the healthy controls. Magnetic resonance spectroscopy scans were taken pre- and post-treatment. Brain metabolite levels were evaluated with respect to clinical headache assessment scores. Acupuncture therapy was found to have a significant decline in the mean VAS score in patients with migraines w/o aura. (7.0±1.5 vs. 6.3±1.3, T=–6.20, ES=0.50, p<0.001). Lessening of the average duration of headache episodes was also seen in patients with migraine w/o aura (12.1±10.5 vs. 10.9±10.1, T=–2.60, ES=0.12, p=0.023) These patients were also found to have a significant increase in the mean level of N-acetylaspartate/creatine (NAA/Cr) in the thalamus bilaterally with a ‘medium effect size (ES) shown in TH-left (1.90±0.22 vs. 2.11±0.35, T=3.43, ES=0.68, p=0.006) and a large ES in TH-right (1.83±0.18 vs. 1.96±0.14, T=3.38, ES=0.81, p=0.006).’ Thus, it was concluded that patients receiving acupuncture therapy showed decreased headache intensity, corresponding to an increased N-acetylaspartate/creatine levels in the thalamus bilaterally as observed on magnetic resonance spectroscopy. This finding showed that acupuncture has biochemical effects that target the brain regions vital for pain awareness (thalamus) with clinically significant effects on pain outcomes⁴⁹.

A meta-analysis assessed the effects of acupuncture on sensory perception. It included 85 out of 3007 identified articles. Out of these, sixty-five studies revealed that a minimum of one sensory threshold is affected by acupuncture. Most of the included research papers evaluated the pressure pain threshold and 80% of them stated post-acupuncture increase in this threshold. Four high-quality meta-analyses showed significant short-term effects on the pressure pain threshold while two high-quality ones showed long-term effects on the pressure pain threshold. More than 60% of studies reported that there was a reduction in sensitivity to noxious thermal stimuli by acupuncture, however, that might be influenced by measuring methods. The improvement in pain intensity after a series of acupuncture treatments as well as during follow-ups (6 weeks and 3 months) was found to be significant (p<0.05), while verum acupuncture was found to be superior to sham acupuncture⁵⁰.

A 24-week randomized controlled trial investigated the long-term effects of true acupuncture in comparison with sham acupuncture as well as the waiting-list control group for the prevention of migraine. The design of the study involved 4 weeks of therapy along with a follow-up of 20 weeks. Random allocation of participants was done to true acupuncture, sham acupuncture, or waiting-list control group consecutively. The study was carried out at 3 clinical sites in China, starting from October 2012 and lasted until September 2014 in outpatient settings. Participants included a total of 249 patients having migraines without aura (on the basis of the criteria of the International Headache Society), aged 18 to 65 years. The frequency of migraine attacks was 2 to 8 times per month. Treatment of true and sham acupuncture was given to participants 5 days a week for 4 weeks (20 sessions). The waiting-list group was not given any treatment but was promised a free acupuncture session after the trial period. Participants were directed to record episodes of migraine in diaries. The results showed that there was a significant difference in the average change in the frequency of migraine attacks between the 3 groups at 16 weeks after randomization (P < .001). The average reduction of frequency of migraine attacks the true acupuncture, sham acupuncture and waiting list group was 3.2, 2.1 and 1.4 respectively; the highest reduction observed in the true acupuncture group followed by the sham acupuncture group (difference of 1.1 attacks; 95% CI, 0.4-1.9; P = .002) and then the waiting-list group (difference of 1.8 attacks; 95% CI, 1.1-2.5; P < .001). Furthermore, the difference between the sham acupuncture and the waiting list group was not statistically significant (difference of 0.7 attacks; 95% CI, −0.1 to 1.4; P = .07). Thus, it was concluded that true acupuncture has value for a long-term reduction in migraine frequency in patients with migraine without aura, as compared to sham acupuncture or waiting list participants⁵¹.

On the contrary, a multicentre, single-blind RCT randomly allocated 480 patients with migraine four groups, 1. Shaoyang-specific acupuncture, 2. Shaoyang-nonspecific acupuncture, 3. Yangming-specific acupuncture or, 4. sham acupuncture (control). 20 acupuncture sessions were given to patients over 4 weeks that included electrical stimulation. The primary outcome was the number of days with migraines over 5 to 8 weeks while the secondary outcomes were the migraine intensity, frequency of attacks, and effect on the quality of life. The results included fewer migraine days over 5–8 weeks for participants in the acupuncture groups as compared to the control group. However, there were no significant differences between treatments (p > 0.05). The number of migraine days significantly decreased over 13 to 16 weeks in all acupuncture groups as compared to the control (Shaoyang-specific acupuncture v. control: p = 0.003; Shaoyang-nonspecific acupuncture v. control: p < 0.001; Yangming-specific acupuncture v. control: p = 0.011). Nonetheless, it was concluded that acupuncture had a clinically minor effect on prophylaxis of migraine as compared to sham acupuncture⁵².

Three multicentre randomized controlled trials (RCTs) were conducted in China, to assess the safety of acupuncture objectively. The adverse events related to acupuncture were explored and their associated risk factors were analyzed. This study included participants who were given acupuncture from three multicenter RCTs for migraine, Bell’s palsy, and functional dyspepsia. The data of 1968 patients about adverse events of acupuncture after treatment was collected from the respective case report forms, as recorded by the acupuncturists. Out of 1968 patients, 74 (3.76%) experienced a single adverse event over the treatment period. The incidence of serious adverse events was not observed, out of whom 73 patients recovered within 2 weeks by symptomatic treatment. The adverse events observed were of 9 types, which included bleeding, skin bruising, subcutaneous hematoma, and needle site pain. The most commonly reported adverse events were subcutaneous hematoma and hemorrhage (10%) at the needling sites. There was the relevance to the incidence of adverse events with age, gender, and anatomical structure of the acupoints. Older patients and those who were males were at a higher risk of such adverse events. Thereby, it was concluded that acupuncture is a safe treatment modality with minimal risk of adverse events in the clinical practice. The adverse events could be avoided in an improved medical environment, better acupuncturist’s expertise, and the creation of mutual trust between practitioner and patient⁵³.

 

 

Methods

 

This literature review evaluates the effectiveness of acupuncture for short- and long-term management of migraine and explores its safety as opposed to the pharmacotherapeutic drugs with respect to traditional Chinese medicine and Western Medicine. Resources used for the completion of the literature review included exploration of numerous books, articles, and websites focused on migraine and its treatment modalities including pharmacotherapeutic drugs and alternative medicine, particularly acupuncture. In order to obtain a complete perspective of acupuncture and its potential effects on patients with acute and chronic migraine headaches the literature reviewed encompassed a short- and long-term as well as prophylactic therapy for migraine disorders.  In order to gain a true appreciation of the limited articles focusing on migraine and its treatment using true and sham acupuncture, appropriate inclusion and exclusion criteria were utilized. Undoubtedly, the inclusion and exclusion criteria should be adequately defined in advance. The inclusion criteria include the general characteristics of the patients such as meeting the diagnostic criteria of the disease; having signed an informed consent, being within the range of age and gender, etc. Exclusion criteria are the attributes that disqualify the subjects from being inducted in the research, concerning subject safety and might not include the aspects that impede the effect⁵⁴. This review paper included Randomized control trials (RCTs) on acupuncture for migraine. The participants with acute or chronic migraine headaches were included, and excluded papers which only consisted of patients having other types of headaches like tension-type headache, cluster headache, headache caused by trigeminal neuralgia, etc. Acupuncture was the intervention that is focused on in this study. Patients 18 to 70 years old with at least two migraines per month in the prior 3 to 6 months, along with satisfactory data completion were included. Patients with pregnancy or malignancy, serious viral or bacterial infections and neuronal disease background were excluded. As for the control groups, studies utilizing no treatment, sham acupuncture, and medication as controls were all included. Medium to high-quality studies including systematic reviews, case studies, randomized control trials, and literature reviews was included – those that conducted statistical analyses (p-values, etc.) using reliable tools and those that defined a clear research question around acupuncture therapy. At least 40 recently published articles were reviewed. After collection of the research articles, they were compared for similarities in research methodology, measurements were recorded, and research findings were tabulated.

 

 

Supporting Evidence

Table 1 depicts the research findings and conclusions about the effectiveness of acupuncture for the treatment of acute migraine. It summarizes the outcomes of acupuncture therapy in patients with migraine, in terms of reduction of the intensity of migraine, the decline in the number of days of a migraine attack, and the effect on frequency and recurrence of migraine after acupuncture treatment. It also represents studies describing the safety of acupuncture and its value for use as long-term therapy for the treatment of chronic migraine. While the choice of acupuncture therapy varies in the studies listed in Table 1, the results are consistent across the board. Most studies utilized the chi-square test for statistical analyses. The Pearson Chi-square test, also called the Chi-square test of independence, is among the most valuable statistics for hypothesis testing with nominal variables, as it’s mostly the case in clinical research. In contrast to other statistics, the Chi-square (χ²) test not only provides data information on the significance of any observed differences but also provides detailed information on the categories that account for any experimental differences. Therefore, the amount and detail of data delivered by this statistical test make it one of the most valuable tests in the pool of researchers’ analysis tools. In addition, the significance test is called the χ² test and should be combined with a suitable test of strength⁵⁵.

Mean visual analogue score (VAS) has also been utilized in a couple of studies shown in table 1. The VAS is an authentic, subjective assessment for acute and chronic pain. a 10-cm line on paper is used with marks that represent a scale between “no pain” and “worst pain”⁵⁶. As shown in studies including Wang L-P et al and Gu T et al that the acupuncture treatment has caused a significant reduction in the mean VAS of migraine from 5.7 ± 1.4 to 3.3 ± 2.5 and 7.0±1.5 to 6.3±1.3 respectively. Table 2 summarizes the pharmacotherapeutic drugs used traditionally for the treatment of acute and chronic migraine, listing down their adverse effects.

Table 2 depicts that most studies found verum acupuncture to reduce the migraine frequency and intensity, marking it as a safe therapy for long-term management of migraine, having minimal to no risk associated. Out of the 10 reviews compiled in table 2, 8 reported that acupuncture was effective in reducing the intensity of migraine as shown by the mean VAS scores and p-values. All but one study which compared the effectiveness of verum acupuncture over sham acupuncture showed that verum acupuncture was better than sham acupuncture in terms of positive results on migraine outcomes. Li Y et al. which showed no value of verum acupuncture over sham acupuncture also reported that the frequency of migraine attacks was reduced with the use of acupuncture treatment.

The first study shown in table 1, conducted by Ahn C-B et al. is a randomized controlled trial that compared the traditional acupuncture (TA) group with a combined acupuncture group, comprising TA and ear acupuncture (EA) treatments. It evaluated the effectiveness of acupuncture for acute migraine episodes in comparison with sham acupuncture. The study was carried out in the Oriental Hospital, Oriental College, Dongeui University, Department of Acupuncture and Moxibustion of Busan, Korea over a period of 8 months from August 2009 to March 2010. In addition, the trial also analyzed 52 books and journals including Acupuncture by Gabriel Stux and the Proceedings and Abstract Book of ICMART 2010. Chi-squared test, t-test, and Fisher’s exact test were carried out for the analysis. T-test was used to evaluate the change in VAS pre- and post-treatment. The statistics were performed through SPSS version 11 (SPSS Inc., Chicago, IL, USA). The inclusion criteria laid down by the International Classification of Headache Society (ICHS) for headache and migraine was used for this study. The major inclusion criteria for headache and migraine included age older than 18 years, 4-6 migraine episodes for the last 4 weeks, first migraine attack to have occurred before 50 years of age, the diagnosis of migraine to have occurred a minimum of 26 weeks prior to the study, and migraine duration to be 4 to 72 hours without medication or a minimum of 2 hours with medication. Patients were to have at least nausea, vomiting, phonophobia, or photophobia with migraine. Patients with severe pain syndromes of the cervical spine, tumors, stroke, or trigeminal neuralgia were excluded. The acupuncture procedure was explained to all participants. An obligatory treatment using Korean Five-Element acupuncture was given to all patients, whereas specific points for the condition and Ah-Shi points were utilized as supplementary individual treatments. 6 acupuncture sessions were given to all patients over 3 weeks, 2 sessions weekly, with at least 1-day gap between sessions. Needles used were all sterile, and disposable, with physicians allowed to choose the needle length and diameter. It was concluded that acupuncture reduces headaches with no significant difference between the different types of acupuncture procedures used and the most significantly reduced ailment was headache among others ²⁸.

 

The second study is a multicenter prospective, single-blinded, randomized parallel controlled trial which compared verum acupuncture with sham acupuncture. The total duration of the study was a baseline period of 28 days of screening, with one acupuncture therapy session followed by a 3-day follow-up. Patients enrolled at preliminary evaluation were invited to make a record of headache diaries for screening. Those who matched the inclusion criterion were categorized into verum and sham acupuncture groups in a 1:1 ratio randomly. The assessors who analyzed the outcome measures were uninformed of group categorization during the study. The design and conduction of this study were done in cooperation by a group of acupuncture experts and practitioners, neurologists, statisticians, and a methodologist^42.

Due to the similarity of elements within the reviewed studies compiled, two studies were chosen as representatives for analysis purposes. The first one, by Wang Y et al. 2015, included volunteers undergoing migraine, and were enlisted from the greater Melbourne area. Participants who met the inclusion criteria of migraine laid down by the International Headache Society (IHS) were included, age between 18 and 80 years, with an existing history of migraine of minimum 12 months, and had at least five days with migraine every four weeks. Patients who were excluded included, pregnant patients as well as those with malignant tumors were excluded; those who received acupuncture treatment in their face, hands, legs, or the front of the body in the preceding six months; those who had a history of head injury or whiplash; those who had a history of heart failure or severe arrhythmia, epilepsy, brain tumor or hemophilia; those who had taken part in another clinical trial in the previous six months; those who had a tension-type headache for more than six days per month; those who were unable to differentiate between migraine attacks and tension-type headache, and; those who did not understand the English language. After a baseline period of four weeks, eligible participants were divided into real acupuncture (RA) and sham acupuncture (SA) groups randomly in a 1:1 ratio, with eight participants in each block. Participants were blinded by their groups with the acupuncturist being aware of the allocation. Moreover, no discussion was allowed between the acupuncturist and participants during the treatment period other than deemed necessary. After one week of therapy, the reliability of the acupuncture procedure was evaluated through a questionnaire. 16 treatment sessions were given to the participants in total, during the treatment duration of 20 weeks. The treatment schedule was two sessions a week for four weeks (eight sessions), one session a week for the next four weeks (four sessions), followed by one session every two weeks for four weeks (two sessions), after that one session a month for the next two months (two sessions). The acupoints selected for the study were the ones laid down by the Standard Acupuncture Nomenclature published by the World Health Organization. The acupuncturist performing the therapy was a certified professional with a five-year bachelor’s degree in acupuncture. Moreover, the acupuncturist had greater than three years of experience and was registered with the Chinese Medicine Registration Board of Victoria, Australia. No adjunct treatment other than the relief medications were allowed during the trial period.

The number of needles used was from 9 to 12 in total for a session with the needles being 0.25 mm in diameter and a length of either 30 mm or 40 mm depending on the location of the acupoints. Needle insertion was done transversely, obliquely, or perpendicularly for RA, 10–30 mm deep, with the induction of De Qi sensation. Needles were maintained for 25 minutes, after which additional stimulation was given every 10 minutes. As for SA, non-insertion and combined insertion procedures were used. The duration, frequency, and intensity of migraine were the primary outcome measures. Migraine intensity was estimated by a 0–10 Visual Analogue Scale (VAS) and a Six-Point Likert Scale. The record was documented by the participants in a headache diary every day throughout the study duration from baseline to follow up. The secondary outcome measures were the use of relief medications for migraine, severity, and quality of migraine, and quality of life. For the measurements of outcomes, the Intention to treat (ITT) analyses were utilized after treatment and follow-up. Chi-square or t-tests were utilized to evaluate the significance of comparison of the sociodemographic features, the number and proportion of adverse effects, and baseline records of headache among the two groups. The short-term and long-term effects of acupuncture were measured using repeated measures of General Linear Model (ANOVA) and paired sample t-tests respectively. Any missing data were replaced through the “Missing Value Analysis” function under “Analysis function” in the Statistical Package for the Social Sciences (SPSS, version 15.0 for windows) software program. This study concluded that Manual acupuncture was more effective as well as a safe treatment for short-term relief of frequent migraine in adults. However, conducting larger studies was suggested⁴⁵.

The second representative study, Xu S et al. 2020 was a randomized, single-blinded, trial carried out in seven centers in China from June 2016 to November 2018. The total duration of the study was 24 weeks, which included four weeks of baseline evaluation, a treatment period of eight weeks after randomization, leading to 12 weeks of follow-up. Written informed consent was taken from all participants before random allocation. The diagnosis of episodic migraine without aura was made by a neurologist based on the International Classification of Headache Disorders (ICHD-3β). Other inclusion criteria included participants between 15 and 65 years of age, the first onset of migraine before the age of 50 with a history of migraine without aura for more than 12 months, 2 -8 migraine attacks during the baseline duration, naivety to acupuncture, and to be able to give informed consent. Exclusion criteria were other types of primary and secondary headaches, history of another serious disorder like, severe mental illness, pregnancy or breastfeeding, and noncompliance to maintain the baseline diary. Additionally, all participants were instructed not to use any other painkillers or treatment interventions. Participants were randomly allocated to manual acupuncture, sham acupuncture, and usual care group on a 2:2:1 ratio. The order of allocation was hidden to maintain blinding of patients, outcome assessors, and statisticians. Therapy was given by 14 licensed and trained acupuncturists who had more than five years of clinical experience. Participants were given 20 sessions of acupuncture of 30 minutes or usual care over eight weeks. 10 sessions were given with a session given every other day, followed by a 9-day gap. Then, another 10 session course was given. Manual acupuncture was performed at 10 mandatory acupoints, with additional acupoints selected based on the patient’s symptoms. Streitberger acupuncture needles were utilized, having dimensions of 0.30 mm diameter and 30 mm length inserted into the deep tissue layers. Manual manipulation of needles was done to stimulate the de-qi sensation. As for the control, non-penetrating sham acupuncture was done at four non-acupuncture points. Usual care of lifestyle changes and migraine self-care was given according to the migraine guidelines developed by the Canadian Headache Society Prophylactic Guidelines Development Group in 2012. In patients with severe migraine (visual analog score >8), diclofenac sodium was allowed as a relief medication.

 

Patients were supervised by independent research assistants for completing their headache diaries in paper from baseline to week 20 and the outcomes were evaluated. The primary outcomes included a change in the average number of migraine days and migraine episodes over 20 weeks after randomization as compared to the baseline (four weeks before randomization). Secondary outcomes were the number of patients attaining a minimum of 50% reduction in the mean number of migraine days during 17 to 20 weeks and alterations in migraine severity as estimated by a visual analog scale, the Migraine-Specific Quality-of-Life Questionnaire (MSQ), the Migraine Disability Assessment Score (MIDAS), the Pittsburgh Sleep Quality Index (PSQI), the Beck Depression Inventory-II (BDI-II) scale, the Beck Anxiety Inventory (BAI) scale, and the average dose of relief medication used from baseline to week 20. Adverse events after each session of acupuncture were recorded by patients including serious pain, palpitation, bleeding, subcutaneous hemorrhage, fainting, and local infection. To test the primary hypothesis, PROC POWER in SAS was utilized which measured that a sample of 135 patients (54 in manual acupuncture, 54 in sham acupuncture, and 27 in usual care) would be required for 90% power at a two-sided significance level of 5%. Thus, 150 patients were selected, with an estimated 10% dropout rate.

 

The data that were missing, were imputed by carrying the last observation forward. Sensitivity analyses in the per-protocol set and safety analyses in the safety set was performed. Continuous variables were presented as the average with median or standard deviation and interquartile range. The Kruskal-Wallis test or analysis of variance was performed based on relevance, for tests across groups. Moreover, the χ² test or Fisher’s exact test was also done. The dominance of manual acupuncture over sham acupuncture could be determined only when both endpoints were statistically significant. For the secondary endpoints, multiple comparisons were made in pairs depending upon Bonferroni adjusted P values and confidence intervals, if a difference noted across the groups was significant. SAS statistical software was used for all statistical analyses. For both categorical and continuous variables, 95% confidence intervals were measured as suitable. Two-sided statistical comparisons were performed with P<0.05 considered as significant. Thereafter, it was concluded that among acupuncture-naive patients having periodic migraine without aura, manual acupuncture therapy led to a significantly greater decrease in the frequency of migraine days and attacks as compared to sham acupuncture or usual care. Thus, for the preventive treatment of migraine, acupuncture can be recommended as an option and clinicians should suggest acupuncture as an option to patients for prevention⁴⁶.

Discussion

Numerous books and published articles were read for this literature review. All research was similar in nature but differed in the population selected and the research environment.  Two published articles were selected as representative samples of research conducted. The findings laid down included that manual acupuncture was more effective as well as a safe treatment for short-term relief of frequent migraine in adults. Among acupuncture-naive patients having periodic migraine without aura, manual acupuncture therapy led to a significantly greater decrease in the frequency of migraine days and attacks as compared to sham acupuncture or usual care. Thus, for the preventive treatment of migraine, acupuncture can be recommended as an option and clinicians should suggest acupuncture as an option to patients for prevention. However, conducting larger studies was suggested⁴⁵.

 

The idea of using acupuncture therapy from traditional Chinese medicine to address migraine disorders has become popular over the past few years. Acupuncture therapy is emerging as one of the most utilized interventions among the alternative integrative medicine modalities in the United States with more than 10 million acupuncture therapies performed annually. Why acupuncture has been becoming popular and accepted, particularly in the West, can be accounted partly for its efficacy and effectiveness for pain relief while partly for the increasing number of scientific studies being conducted to prove its effectiveness. Chinese researchers have explored Western medicine since the 1950s and have been trying to integrate acupuncture into it. By integrating knowledge with novel technologies, new and effective methods of therapy have been devised. With the amalgamation of Eastern and Western practices, practitioners have been able to provide treatments to patients in an upgraded and wholesome manner. The integration of acupuncture with Western medicine is executed by locating the specific areas of stimulation called acupoints with needling techniques. This needling influences the physiology of the target areas under treatment to treat many kinds of ailments. The National Institute of Health has also funded studies demonstrating acupuncture therapy to be effective for the treatment of migraines, arthritis, and chronic pain⁵⁷.

The present review demonstrated that acupuncture therapy effectively decreases the number of migraine days, frequency of migraine episodes, and improves the quality of life when compared with sham acupuncture. Most studies suggested that verum acupuncture is superior to sham acupuncture^{42, 44, 46, 47, 50, 51}. Verum acupuncture was also found to have comparable effects as preventive medications for the prophylaxis of migraine attacks⁴⁴ and cause a reduction in the use of acute traditional medications^42. The majority of studies conducting a safety check on acupuncture regarded acupuncture as a safe therapy with very minimal and superficial adverse effects that could easily be taken care of and there was no serious side effect, necessitating subject-withdrawal the trials. One such study concluded that any adverse events that might occur could even be avoided in an improved medical environment, better acupuncturist’s expertise, and the creation of mutual trust between practitioner and patient⁵³. It was also reported the effects of acupuncture lasted over time with only a small reduction (about 15%) in treatment effect after 1 year, concluding that acupuncture is efficacious for treating chronic pain, with treatment effects continuing over time^{32, 47, 48}. The findings suggest that the effects of acupuncture on migraine treatment were mediated not only by physical blockade of nervous conduction but were also brought about biochemically by targeting the brain regions vital for pain awareness (thalamus) with clinically significant effects on pain outcomes. This corresponds to the increased levels of N-acetylaspartate/creatine in the thalamus bilaterally as observed on magnetic resonance spectroscopy⁴⁹.

 

Moreover, true acupuncture was also found to have value for long-term reduction of migraine frequency in patients with migraine without aura, as compared to sham acupuncture or waiting list participants. This was supported by a 2-year study conducted at 3 clinical sites in China, based on a study design involving 4 weeks of therapy along with a follow-up of 20 weeks⁵¹. On the contrary, one study claimed that over 5–8 weeks of acupuncture therapy showed insignificant (p > 0.05) reduction in migraine days as compared to the control group. However, the same study stated that the number of migraine days significantly decreased over 13 to 16 weeks in all acupuncture groups as compared to the control (p = 0.003). Nonetheless, it was concluded that acupuncture had a clinically minor effect on the prophylaxis of migraine as compared to sham acupuncture⁵². This inconsistency between the findings and conclusion suggested that there was room for a more large-scale study for a longer duration to be conducted with an anticipated chance of positive results. Thus, this scenario suggested that the conclusion was based on a high risk of bias as it was clearly not in concurrence with the findings.

 

Limitations

The effect of acupuncture on other types of headaches as well as ailments of other kinds have in different parts of the body not been analyzed to check the effectiveness of acupuncture. This is because acupuncture’s effect on conditions other than migraine is not our research question and out of scope for this review, thus it remains untalked about. However, studies that investigate the effect of acupuncture on a large scale and duration, not only on migraine but on other illnesses can define the integrity and value of acupuncture thus, helping its integration or retrieval from Western medicine.

 

Conclusion

From the findings presenting in this review, one can infer that acupuncture is effective in reducing the number of days and frequency of migraine. It can be a safe and effective acute and prophylactic therapy for frequent migraine sufferers for both short- and long-term management. Acupuncture is suggested to be considered in future guidelines as the recommended option for patients who are either non-compliant to use prophylactic drugs or when these drugs are not effective⁴⁶.

 

In a broader view, being an incapacitating condition, migraine increases the risk of other health issues such as depression, mood swings, constant visual discrepancies, poor quality of life, and inadequate focus and performance. Hence, the overall burden on society not only in terms of healthcare cost but also economic growth can be enormous. Acupuncture has the merits of being a low-cost and low-risk treatment and can be utilized in a variety of settings such as in a hospital setting, at the specialists’ office, and anywhere that migraine may consume the patient. It is likely to become a standard tool utilized as a part of treatment plans for diagnoses far beyond migraine headache, with our contribution in this review being the study, compilation, and presentation of the research conducting up till now. More large-scale studies are needed and analysis of the level of potential of acupuncture for replacement with traditional therapeutic drugs is also warranted.

 

Tables

Table 1. Research findings about the effectiveness of acupuncture

Reference	Findings	Conclusion	Analysis
Ahn C-B et al. 2011	p = 0.968 for various types of acupuncture techniques applied F = 4.399, p = 0.018 for headache as compared to other disorders	No significant difference between the various types of acupuncture techniques applied. Headache was the most significantly relieved disorder among trigeminal neuralgia and retro-auricular pain in Facial Palsy.
Wang L-P et al. 2012	Mean VAS scores reduction about 24 hours post-treatment Verum acupuncture 5.7 ± 1.4 to 3.3 ± 2.5 Sham acupuncture 5.4 ± 1.3 to 4.7 ± 2.4 Difference between the effectiveness of outcomes between the two groups P = 0.001	Verum acupuncture group was superior to sham acupuncture group for pain relief     There was a significant difference between the effectiveness of outcomes between the two groups
Yang M et al. 2020	Greater reduction in headache intensity than analgesic medications (p<0.00001)	Significant reduction in the severity of headache immediately after the acupuncture treatment, as compared to analgesic medications Acupuncture was more effective than medications after 3 and 6 months post-treatment Acupuncture was safe and only had minor adverse effects which did not require any further treatment, unlike the analgesic medications	The conclusions were inconsistent with the findings. A small sample size of each study Insufficient, weak acupoints for reproductive organ were selected Unclear of the high risk of bias due to sampling error
Wang Y et al. 2015.	Migraine days RA: 5.2 ± 5.0 SA: 10.1 ± 7.1 (P=0.008) Reduction in the intensity of migraine RA group: 2.18 ± 1.05 SA group 2.93 ± 0.61 (P=0.004) RA responders: 19 SA responders: 7	The RA group showed significantly fewer migraine days as compared to the SA group The severity of migraine was found to decrease in RA group more than the SA with more responders and increased pain threshold	High-quality studies, all reporting the efficacy of acupuncture for the treatment of migraine, showing: manual acupuncture to be superior to sham acupuncture, to reduce the intensity and improve outcomes of headache through specific acupoints that bring about biochemical changes in the brain.
Xu S et al. 2020	Reduction in the mean number of migraine days: At weeks 13 to 16 – 3.5 for MA 2.4 for SA (P=0.005) At weeks 17 to 20 – 3.9 for MA 2.2 for SA (P<0.001) The decline in the mean number of migraine attacks: At weeks 17 to 20 – 2.3 for MA 1.6 for SA (P<0.001). No report of severe adverse events	Manual acupuncture showed a significant decrease in migraine days than sham acupuncture Manual acupuncture showed a significantly greater decline in migraine attacks than sham acupuncture
Vickers A J et al. 2017	Real acupuncture vs sham acupuncture and no acupuncture control for all pain conditions – Ps < .001 Reduction in treatment effect after 1 year – approximately 15%	Real acupuncture was found to be superior to both sham and no acupuncture control for all pain conditions. Acupuncture effects last over time with only a small reduction  in treatment effect
Chang A et al. 2016	1st postoperative day – patient treated for nausea 2nd postoperative day – patient treated for nausea 3rd postoperative day – patient developed a headache in the occiput and bilateral eyes coupled with photosensitivity and nausea (PNRS 5-6/10) 4th postoperative day – PNRS of 10 which was not eased by sumatriptan or cyclobenzaprine. The first acupuncture therapy performed (a decrease in PNRS to 7 over about 3 hours). 5th postoperative day –   second acupuncture therapy performed (PNRS reduced from 8 to 5 within 30 minutes) 6th postoperative day – patient ambulated, had a regular diet and headache PNRS decreased to 2/10 with oral pain killers before being discharged.	The postoperative patient was unresponsive to traditional pharmacotherapies such as intravenous caffeine and an epidural blood patch but was successfully relieved by adjunct acupuncture.
Gu T et al. 2018.	Mean VAS score in patients with migraine w/o aura 7.0±1.5 vs. 6.3±1.3 T=–6.20, ES=0.50, p<0.001 The average duration of headache attacks in patients with migraine w/o aura 12.1±10.5 vs. 10.9±10.1, T=–2.60, ES=0.12, p=0.023 The mean level of N-acetylaspartate/creatine (NAA/Cr) in the bilateral thalamus Effect size (ES) in TH-left 1.90±0.22 vs. 2.11±0.35, T=3.43, ES=0.68, p=0.006 ES in TH-right 1.83±0.18 vs. 1.96±0.14, T=3.38, ES=0.81, p=0.006	Significant reduction in pain intensity of migraine w/o aura through acupuncture Significant reduction of the mean headache duration in migraine w/o aura Significant increase in the mean level of NAA/Cr in thalamus bilaterally	Acupuncture has biochemical effects that target the brain regions vital for pain awareness (thalamus) with clinically significant effects on pain outcomes.
Li Y et al. 2012	Reduction in the number of migraine days over 13 to 16 weeks in all acupuncture groups as compared to the control Shaoyang-specific acupuncture v. control: p = 0.003;   Shaoyang-nonspecific acupuncture v. control: p < 0.001;   Yangming-specific acupuncture v. control: p = 0.011 Differences between treatments – p > 0.05	The number of migraine days significantly decreased over 13 to 16 weeks in all acupuncture groups as compared to the control There were no significant differences between treatments Acupuncture had a clinically minor effect on prophylaxis of migraine as compared to sham acupuncture
Zhao L et al. 2017	The average change in the frequency of migraine attacks between the 3 groups at 16 weeks – (P < .001). The average reduction of frequency of migraine attacks the true acupuncture – 3.2, Sham acupuncture – 2.1 Waiting list group – 1.4 The difference of attacks – True vs. sham acupuncture –  95% CI, 0.4-1.9; P = .002 True vs. waiting-list group – 1.8 attacks; 95% CI, 1.1-2.5; P < .001 Difference between sham acupuncture and a waiting list group – 0.7 attacks; 95% CI, −0.1 to 1.4; P = .07.	A significant difference in the average change in frequency of migraine attacks between the 3 groups at 16 weeks after randomization The highest reduction observed in the true acupuncture group followed by the sham acupuncture group The difference between sham acupuncture and waiting list group was not statistically significant.	True acupuncture has value for a long-term reduction in migraine frequency in patients with migraine without aura, as compared to sham acupuncture or waiting list participants. Why was this a high-quality study?
Baeumler PI et al. 2014	Acupuncture decreased pain induced by blunt pressure mediated by deep tissue nociceptors (Aδ- and C-fibers) >80% of the studies (27 out of 35) Reduction in pain intensity after a series of acupuncture treatments and during follow-ups (6 weeks and 3 months) p<0.05	Post-acupuncture increase in pressure-pain threshold was found Significant improvement in pain intensity after a series of acupuncture treatments and during follow-ups (6 weeks and 3 months) Verum acupuncture was found to be superior to sham acupuncture

 

 

Table 2. Pharmacotherapeutic drugs for the treatment of Migraine and their side effects.

Medications	Side effects
Analgesics;  ibuprofen, aspirin, naproxen, diclofenac, acetaminophen	Medicine-overuse headache Ulcers and bleed in the gastrointestinal tract
Triptans; sumatriptan, almotriptan, frovatriptan, eletriptan, zolmitriptan	Dizziness Tingling Flushing Chest tightness Risk of heart attack or stroke
Tricyclic Antidepressants; amitriptyline, nortriptyline, dosulepin, venlafaxine	Sleepiness Weight gain Dry mouth Reduced libido
β-Blockers; propranolol, metoprolol, timolol, atenolol, nadolol	Nausea Fatigue Dizziness Depression Insomnia Reduced blood pressure
Angiotensin Blockers; Candesartan, Telmisartan	Dizziness Fainting Fatigue Vomiting Upset stomach Hyperkalemia Tissue swelling Liver Failure Kidney Failure

Table 3. Research findings showing outcomes of acupuncture for the treatment of migraine

Reference	Reduction in migraine frequency	Reduction in migraine intensity	True acupuncture better than sham acupuncture	Acupuncture is safe	Effective for long-term treatment	True acupuncture not better than sham acupuncture	Not effective
Ahn C-B et al. 2011		ü		ü
Wang L-P et al. 2012		ü	ü
Yang M et al. 2020	ü	ü	ü	ü
Wang Y et al. 2015.		ü	ü	ü
Xu S et al. 2020	ü	ü	ü	ü
Vickers A J et al. 2017		ü	ü		ü
Zhao L et al. 2017	ü		ü
Baeumler PI et al. 2014		ü	ü		ü
Zhao L et al. 2011		ü		ü
Li Y et al. 2012	ü					ü

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