The goal of this study is to assess the effectiveness of Acupuncture compared with Sham Acupuncture and medication in the treatment of Migraine.
Migraine is a common neurological disorder, which burdens individuals and society all over the world. Acupuncture treatment for Migraine has been widely used in clinics. However, efficacy remains controversial.
Migraine is a prevalent neurovascular headache disorder. The World Health Organization (WHO) ranks migraine as the third most prevalent medical condition and the second most disabling neurological disorder in the world (Lancet, 2016; Neurology, 2018). Migraine sufferers typically have severe headaches which feel like a throbbing pain at the front or on one side of the head. According to the National Institute for Health and Clinical Excellence (NICE) (2011), there are 190.000 migraine attacks every day, and six million sufferers in the UK, two-thirds of them are women.
1.1. Setting Migraine in Context
1.1.1) Impact on General Wellbeing
Migraineur also suffer secondary symptoms of nausea, vomiting and increased sensitivity to light and sound. Freita et al. (2007) stated that a patient with Migraine might also experience periods of anxiety in fear of the next headache episode. According to Bigal et al. (2009), Migraine sufferers have a higher risk of cardiovascular and cerebrovascular disease than those without Migraine. Llop et al. (2016) stated that Migraine sufferers are more likely to develop epilepsy and depression. Their quality of life can be much affected, and Migraine brings a heavy burden to family and society (Reto et al. 2018; Colman et al. 2016). The causes of Migraine are unknown, and there is no specific method to test it. Therefore, the prevention and treatment of Migraine have become an urgent matter of debate.
1.1.2) The Pharmacological Approach
The European Federation of Neurological Societies (EFNS, 2009) recommends medication to treat acute Migraine and Prophylaxis of Migraine, the oral non-steroidal anti-inflammatory drug (NSAID) and triptans and β-blockers (Flunarizine) for the Prophylaxis of Migraine (Evers et al. 2009).
Smitherman et al. (2013) stated that triptans accounted for almost 80% of anti-migraine analgesics prescribed in 2009. It also noted that migraine medication is associated with the increased risk of other physical and psychiatric co-morbidities, and the frequency of headaches can increase. Alen et al. (2003) indicated that one-third of the patients treated did not have pain relief within 2 hours after taking the triptans. Laszlo et al. (2017) commented that their use in the clinic is limited. The researchers also have a therapeutic challenge with frequency of episodes and chronic Migraine.
According to National Health Services (NHS) (2018), the number of painkillers used to treat migraine attacks can also result in side effects, including nausea and vomiting. Thorlund et al. (2016) stated migraineur taking any form of painkillers regularly can make migraines worse, resulting in a “medication overuse headache” or “painkiller headache”. NICE (2015) recommended the following medication treatments for migraine prophylaxes: Topiramate, Propranolol and Amitriptyline.
NICE (2015) also mentioned that these medications could cause medication overuse including headache and other significant side effects such as nausea.
1.1.3.) Impact of Economic Problems
The burden of Migraine has caused substantial financial issues worldwide. Munakata et al. (2009) stated a person of episodic Migraine costs $1,757 annually on average in the USA in a study of the American Migraine Prevalence and Prevention (AMPP). Linde et al. (2012) conducted a cross‐sectional survey in eight countries representing 55% of the adult EU population. It has estimated a mean annual cost of Migraine per person of €1,222 and a total yearly cost of €111 billion for adults aged 18–65 years. The burden of Migraine has caused migraine sufferers extensive health issues, and quality of life decreased as well as the substantial economic cost to health services.
1.1.4.) Acupuncture as a Treatment Therapy for Migraine
Acupuncture has been used to treat migraine attacks as well as preventing Migraine in China and worldwide. In a Cochrane systematic review, Linde et al. (2016) found that Acupuncture treatment can reduce the frequency of migraine headaches. The results show that there is the efficacy of real Acupuncture over Sham Acupuncture, but the effect is minor. It suggests that Acupuncture may be at least similarly effective as treatment with prophylactic drugs and has fewer side effects compared to conventional Medicine. However, the trials are still not long enough, typically less than one year. Wang et al. (2011) found that Acupuncture was more effective than flunarizine in decreasing days of the migraine attack in a single-blind, double-dummy, randomised, parallel control trial. Arnaldo et al. (2015) reported that Acupuncture has a positive effect; however, there is no significant difference between real and Sham Acupuncture in a systematic review.
NHS has recommended Acupuncture to treat migraineurs since 1997. In 2020, the NHS still recommends Acupuncture as an alternative therapy to prevent Migraine if medicines are unsuitable.
The number of RCTs of Acupuncture therapy compared with Sham Acupuncture or medication for Migraine has increased in recent years. These studies vary considerably in quality and methodology, making Acupuncture treatment controversial. There was also a lack of evidence to prove the efficacy and safety of Acupuncture to treat Prophylaxis of Migraine
The purpose of this critical literature review is to investigate and evaluate randomised controlled trials (RCTs) to explore the evidence of the efficacy of Acupuncture in the management of Migraine compared to Sham Acupuncture (SA) and Western Medicine (WM) in treating migraine disorders. Therefore, the quality of these RCTs must be assessed, and definitive guidelines set. Migraineurs require adequate treatment. Therefore, healthcare professionals need evidence-based research to guide professional practice.
This critical literature review investigated the question of whether Acupuncture is used as a safe and effective method to treat prophylaxis migraine?
2. Literature review
2.1. The Western Medical (WM) Perspective of Migraine
The International Classification of Headache disorders (2018) classified about 30 varieties of Migraine. Six main types of Migraine were classified – Migraine without aura, Migraine with aura, chronic Migraine, complications of Migraine, probable Migraine and episodic syndromes, which makes it difficult for the health practitioner to diagnose. Furthermore, the causes of the complex pathophysiology of Migraine is still not fully understood (Ninan et al. 2011).
The NHS of England (2018) stated that the causes are unknown. Some triggers may affect nerve signals and chemicals and blood vessels in the brain to cause abnormal brain activity. The patients are customarily given painkillers by the General Practitioner to treat the symptoms during an attack.
2.1.1. WM Pathophysiology
The pathophysiology of Migraine is unclear; however, there are some theories. Goadsby et al. (2017) stated that Trigeminovascular complex, cortical spreading depression and neuronal sensitisation are the most common hypothesises. Cutrer et al. (2019) in a literature review also stated that the hypothesised theories: cortical spreading depression in the neuron and ganglion self-produce the electric wave and cause depolarisation spreading across the cerebral cortex. Cui et al. (2014) stated the cortical spreading depression might be a cause of migraine aura. Figure 1 shows the Pathophysiology of Migraine.
Pathophysiology of Migraine. Trigeminocervical complex=TCC; periaqueductal gray=PAG; pontine locus coeruleus=LC; nucleus raphe magnus=NRM. Reproduced from Goadsby PJ. Neurol Clin. 2009;27:335-60.
Figure 1. Pathophysiology of migraine
2.1.2. WM migraine diagnostic feature of Migraine
Table 1- Diagnostic feature of Migraine (NICE 2012)
|Feature of migraine (with or without aura)|
|Moderate or severe pulsating Pain which can be located either bilaterally or unilaterally|
|Hypersensitivity to light and /or sound, or nausea and/or vomiting|
|Pain is aggravated by daily activity or prevents participation in daily routine|
|Symptoms lasting 4-72 hours in adults or 1-72 hours in 12-17 year olds|
|Frequency of migraine on less than 15 days per month is classified as episodic migraine (with or without aura). If attacks occur more than 15 days per month and occur over more than three months, the classification is chronic migraine (with or without aura)|
|Additional features of migraine with aura|
|Visual manifestations (such as flickering lights, spots or lines and partial loss of vision), with accompanying sensory symptoms (such as numbness and/ or pins and needles) and possible speech disturbance.|
|These symptoms may occur with or without the headache and could be progressive in nature, lasting in excess of 5 minutes and up to 60 minutes.|
2.2. The Chinese Medicine (CM) perspective of Migraine
2.2.1. CM Pathophysiology of Migraine
Flaws (1990) suggested that a migraine headache could be caused by external, internal pathogens and traumatic injury.
- a) The External pathogen or feng xie (as Wind-Cold, Windy Heat and Wind Dampness) attack the channels and collaterals of the head. So, the qi and blood are blocked; they cannot flow freely and can cause a headache. The person feels like a tight band is wrapped around the head or feels a heavy head.
b). The internal pathogenic facts are Dampness, Phlegm, and stagnant Blood. Lung, Spleen and Kidney fail to transform, and transport jin ye properly causing Internal Dampness. This leads to Dampness drafted up to the head, then the qi and Blood are obstructed. Dampness is lingers in the body; resulting in Phlegm, the Phlegm can obstruct the Jing Luo (Channels and Collaterals) leading to dull Pain and dizziness, and even loss of consciousness.
c). Traumatic injury, weather a blow or a cut, can cause a rupture in the Jing Luo (Channels and Collaterals). The qi and Blood flow out of their pathway, causing swelling, inflammation and Pain. Stagnant Blood obstructing the Sun Luo or capillaries may cause a recurrent headache.
2.2.2. The Signs and Symptoms of Migraine with Five-Phases.
Flaws (1990) and Stephenson (2017) described the typical symptoms of Migraine from the Five Phase theories. In Chinese Medicine, the intense throbbing on one side of the temple position of typical migraine syndrome suggests that the pain manifestation of a mixed or full condition. The organs are associated with Five-Phases. Figure 2.
Figure. 2. Organs association with Five-Phases.
The Five phases are in the Sheng and Ke cycle to maintain homeostasis. qi and Xue deficiency of one organ can lead to other organ imbalance and manifest symptoms. An imbalance of the Liver may cause aura. Stagnation of the Liver qi can invade the Stomach, causing nausea, vomiting and diarrhea. Kidney Jing deficiency can lead to the Liver yin, the Heart yin deficiency and to the Liver yang rising and the Heart Fire
Maciocia (2008:11) stated the pathology of Migraine, as shown in Table 1.
Table 1. The pathology of migraine.
|Excess of yang||Deficiency of yang||Excess of yin||Deficiency of yin|
Liver yang rising,
Intense and usually throbbing
Deficiency of Stomach-qi or Kidney yang (occipital)
Dull and mild
Dampness and Phlegm
Dull but intense
Deficiency of Liver or Heart Blood deficiency of yin.
Kidney essence deficiency
Dull and mild
Maclean and Lyttleton et al. (2010) stated that the migraine headache might be caused by cold affecting the Liver and Stomach. The counter flow of yang qi through the jue yin channel blocks the Middle burner by the Cold. The Cold stagnated in the Middle burner and affected qi dynamic free flow. The obstructed qi count flow to the vertex of the head through the jue yin channel.
In recent years, studies have been conducted on the hypothesis of Acupuncture to treat Migraine. Arne (2009) and Ellerbrock et al. (2013) suggested that the effect of Acupuncture treatment involves the nociceptive modulation that is associated with several pathological processes; including spread activation and deactivation of the cortical trigeminovascular pain pathway.
It is unclear, however, in a study, Gu et al. (2018) concluded, that a significant amount N-acetyl aspartate (NAA) /creatine was increased in bilateral thalamus in Migraine without aura after Acupuncture treatment.
3.1. Search Strategy
An online electronic search via NHS Open Athens and the University of Greenwich portals was conducted, including Google Scholar. Table 2 outlines the sources used. The International College of Oriental Medicine library resource has also been accessed.
Search items used: Acupuncture, migraines, prophylaxis.
An initial online search was carried out in November 2019.
Table 2. Online searches carried out in November 2019
|Databases searched||Primary search terms||Filters applied where possible|
Elsevier Health Science
The World Journey of Acupuncture (WJAM)
The Journey of Chinese Medicine (JCM)
The Journal of the American Medical Association (JAMA),
British Medical Journey (BMJ)
Canadian Medical Association Journal
Published after 2011
After removing duplicates, abstracts identified at this first stage were manually screened for conformity to predetermined inclusion/ exclusion criteria (Table 3).
Table 3. Inclusion/Exclusion Criteria
|RTCS in Acupuncture for migraine prophylaxis.||RCTs without a control group. The article is not RTC, like prospective controlled study.|
Manual Acupuncture (Verm/True), Electro Acupuncture (EA)
|Ear Acupuncture, acupressure and laser, auricular therapy.|
|RTCs that examine the use of Acupuncture for migraine headache||Articles which discuss Acupuncture treatment for tension-type of headaches, cluster headaches. Secondary headaches: neuralgia of the face or head disorder.|
|Articles are less than ten years old. The information is likely to be more accurate and reliable.||Articles more than ten years old. The information may not be reliable or incorrect.|
|Peer-reviewed, as it is considered a trusted view of scientific communication.||Not peer-reviewed or small sample. As the information may be less reliable.|
|Articles must be free due to financial constraints.||Articles which must be paid for.|
|Articles are written in English or translated into English||Articles are written in another language|
|RCTs with a trial period of more than four weeks and the size of the trial must be more than 40 participants. (stand level of the random controlled trial)|
RCTs with a trial period of less than four weeks to finish.
Small trials with less than 40 participants.
|Papers are from reliable academic websites, such as nursing, medical and health journals.||Publications from unreliable internet sources, such as blogs and Twitter.|
3.3. Assessment of Methodological Quality of RCTs.
The methodological quality of RCTs was assessed using the modified five-points Jadad scale. STRICTA Checklist/CONSORT2010 Statement. The Cochrane Risk of Bias for all included trials are in Table 4 and 5.
|Musil et al. (2018) Czech||Li et al. (2012) China||Wang et al. (2015) Australia||Zhao et al. (2018) China||Mohsen. et al. (2013) Iran||Yang et al (2011) Tai Wan China||Wang et al. (2011) China|
|Allocation sequence adequately randomly generated?||Y||Y||Y||Y||U||U||Y|
|Blinding of participants||Patient||N||Y||Y||Y||Y||U||Y|
|Incomplete outcome data adequately addressed?||Y||U||Y||Y||N||Y||Y|
|Free of selective reporting?||U||U||U||U||U||U|
|Free of other problems that could increase the risk of bias?||N||N||N||N||N||N||N|
|Allocation adequately concealed?||U||U||Y||U||Y||Y||Y|
|Y= Low risk of bias N= High risk of bias U= Unclear risk of Bias|
Table 4 Cochrane Risk of Bias assessment for all the trials.
Table 5: JADAD assessment for all included trials
|Frantisek, M. et al (2018) Czech||Li, Ying.et al (2012) China||Wang Yang Yi et al (2015) Australia||Zhao ling et al. (2018) China||Mohsen. et al. (2013) Iran||Yang, C, P. et al (2011) Tai Wan China||Wang, L, P et al. (2011) China|
|Randomisation method appropriate||1||1||1||1||0.5||0.5||1|
|Blinding method appropriate||-1||1||1||1||-1||-1||1|
|Number and reason for withdrawals given||1||0.5||1||1||-1||1||1|
|Total JADAD score||3||4.5||5||5||2.5||3.5||5|
|Total Score < 3: Low-quality trial|
3.4. Study selection and data extraction
A total of 266 studies were initially searched. For abstracts remaining after the first pass screen, full papers were obtained and retrieved, and pass screen performed on the same basis. Citations in these papers were also checked. Fifty-eight studies were selected after reading the title and abstract, and 7 RCTs were included in the overview after viewing full texts. The study selection process is shown in Figure.3.
Figure 3. Flow diagram of the literature selection process.
The search process (Figure 3) yielded seven full-text papers, summarised in CASP table. Appendix 1.
4.1. Classification of Studies and Migraine Conditions.
Seven trails, including 1160 participants, met the selection criteria. Five trails (Musil. et al. 2018; Wang et al. .2015; Yang et al. 2011; Mohsen et al. 2013; Wang et al. 2011) were 2-armed, 1 study (Zhao et al. 2017) was three-armed, one review (Li, Y. et al. 2012) was four armed
Two studies (Li et al. 2012; Zhao et al. 2017) were conducted around Electrical Acupuncture(EA) compared to Sham Acupuncture (SA); Two reviews (Frantisek, M. et al. 2018; Yang et al. 2011) were True Acupuncture(TA) compared to prophylactic medications; Two reviews (Wang et al. 2015; Mohsen et al 2013) were True Acupuncture compared to Sham Acupuncture; 1 study(Wang et al. 2011) was True Acupuncture with placebo medication vs medication with Sham Acupuncture. All trials used parallel – group designs. There were no cross-over studies. Study size ranged from small pilot 50 participants to 476 participants. Two studies were rated for the poor quality of RCTs (Jadad Score<3); the remaining five were identified for relatively high- quality RCTs (Jadad>3).
Three studies (Zhao et al. 2017; Mohsen et all 2013; Wang et al. 2011) included the Migraine without aura subtype; Three studies (Li et al. 2012; Wang et al. 2015; Yang 2011) did not mention Migraine with or without aura subtype; One ( Musil et al. 2018) study is Migraine with or without aura subtype.
In all the seven trials, participants kept a headache diary to record the time, frequency, location, duration, and intensity of Migraine attacks: taking acute medications and adverse effects.
The characteristics of the trials included are shown in Table 6
Table 6. General Characteristics of the literature included.
|Author /year/ country|
|Treatment group||Control group||Duration of treatment||Follow-up||Outcome indicator|
|Musil et al (2018)||42/44||TA||Standard pharmacological||12 weeks||6 months||Primary: FM, NM, VAS. Secondary: DM, PR, ACT/DDDS, VAS, MIDAS,|
|Li.et al (2012)||121,119,118/118||EA||SA||4weeks||12weeks||Primary: NM. Secondary: FM, VAS, IM, MSQ|
|Wang et al. (2015)||26/24||TA||SA||20 weeks||One year||Primary:FM,NM,DM,PR,VAS,SM.Secondary:McGill,MSQOL,MQS|
|Zhao et al. (2017)||TA83/SA80/WL82||EA||SA, WL||4 weeks||24weeks||Primary: FM, VAS.Secondary: NM, AHMT, SM, VSA, MSQ, SAS, SDS|
|Mohsen et al. (2013)||50/50||TA||SA||4weeks||4months||Primary: NM|
|Yang et al (2011)||33/33||TA||Topiramat:25mgQD 1week,100QD||12 weeks||Primary: FM, NM. Secondary PR, AHMT, MIDAS, HADS, BDI-II, SF-36|
|Wang et al. (2011)||62/61|
Flunarizine with SA,
10mg QN 2weeks, 5mg QN 2weeks
|4weeks||12 weeks||Primary: PR. Secondary: NM, VAS, SF-36, AHMT|
|Notes: ER, effective rate; FM, frequency of Migraine; mm, headache intensity; DM, duration of Migraine; SM, the severity of Migraine; PR, the proportion of responders( defined as the proportion of patients with a reduction of migraine days by at least 50%); NM, Number of migraine days; VAS, visual analogue scale; SF-36, 36-item short-form health survey; MIDAS, Migraine Disability Assessment; HADS, Hospital Anxiety and Depression Scale; BD-II. Risk of Bias included studies. ACT/DDDS, Anatomical Therapeutic Chemical Classification System/defined daily doses. TA, true Acupuncture; SA, Sham acupuncture.CG, Control Group. IM, Intensity of Migraine. AHMT, Acute headache medications|
4.2. The outcomes
4.2.1 The frequency of Migraine (FM)
The statistical analysis results showed that the change of FM was significantly different for True Acupuncture vs Sham Acupuncture in three trials (Li et al. 2012; Wang et al. 2015; Zhao et al. 2017). A more significant reduction (Zhao et al. 2017; Wang et al. 2015) was found in the TA than in the SA group 95%CI,0.4-1.9; P= 0.002) at weeks16 treatment after randomisation. One trial (Li et al. 2012) reported that FM was significantly lower in Shao yang (TA) than in SA during week 5-8.
4.2.2. The Number of Migraine days (NM)
Two trials (Zhao et al. 2017; Wang et al. 2011) suggested that the number of migraine days of the Acupuncture group was significantly reduced compared with the control group (P<0.01) after four weeks of treatment.
Two trials (Musil et al. .2018) concluded that there was a more significant reduction in the number of migraine days between the TA and Medication control group,95% CI:-6 to-2 in the trial at the end of the six months follow up period. One trial (Yang et al. 2011) reported that Acupuncture was statistically significantly more effective than Topiramate in reducing the NM (P<0.01). One trial (Li et al. 2012) reported a significant reduction in the number of days with migraine in all TA groups compared to the SA group≤0.003, during weeks13-16. In one trial (Musil et al. 2018), the results were unclear.
4.2.3. The Proportion of Responders (PR)
Four trials (Wang et al. 2011; Wang et al. 2015; Musil et al. 2018; Yang et al. 2011) suggested that the PR, response defined as at least a 50% reduction in average monthly migraine day frequency TA compared to CG (P< 0.05), during the trial or at the end of the intervention in either True Acupuncture vs Sham Acupuncture or TA vs Medication group.
4.2.4 Visual Analogue Scale (VAS)
Five trials (Musil et al. 2018; Wang et al. 2015; Li et al. 2012; Zhao et al. 2017; Wang et al. 2011) conducted the VAS as an outcome. In two trials (Zhao et al. 2017; Musil et al. 2018) statistical analysis suggested that the VAS score of the Acupuncture group was significantly reduced compared to the control group. Two trials (Wang et al. 2015; Wang et al. 2011) reported the VSA score was no different between the Acupuncture group compared to the control group. One trial (Li et al. 2012) did not give a precise result.
4.2,5. Migraine Disability Assessment Scale (MIDAS)
Musil et al. 2018 found a significant decrease in the MIDAS score in the Acupuncture group with no significant inter-group difference (P>0.05). Yang et al. 2011 found a significantly better improvement when compared to the Topiramate group(P<0.5) in the MIDAS scale. Three trials (Wang et al. 2015; Li et al. 2012; Zhao et al. 2017) concluded there was an effect in improving the specific quality of life, but no difference between the TA and SA group.
Five of the seven trials found a considerable reduction of medication taken between the TA compared to CG after the end of the session.
4.2.6 Drop out Reason
Five of seven trials (Musil et al. 2018; Wang et al. 2015; Zhao et al. 2017; Yang et al. 2011; Wang et al. 2011) discussed the drop out number and drop out reasons. The main reasons were missing diaries, time restriction and inability to tolerate Acupuncture needling. One trial (Li et al. 2012) mentioned the drop out reasons were unclear. One trial (Mohsen et al. 2013) did not indicate the dropout reasons.
5.1. Overall Effectiveness
Of the seven trials, three trials (Yang et al. 2011; Mohsen et all 2013; Wang et al. .2015) concluded that Acupuncture could be used as an alternative and safe prophylaxis for frequent Migraine. One trial (Musil et al. 2018) found that Acupuncture could reduce symptoms and medication use, both short term and long term, as an adjuvant treatment in migraine prophylaxis. One trial (Zhao et al. 2017) concluded that True Acupuncture might be associated with long-term reduction in migraine recurrence compared with Sham Acupuncture. One trial (Li et al. .2012) concluded that Acupuncture appeared to have a clinically minor prophylactic effect for Migraine. One trial (Wang et al. 2011) reported Acupuncture was more effective than Flunarizine in decreasing days of migraine attacks, no significant differences were found between the two groups in the reduction of pain intensity and improvement of the quality of life.
5.2. Reporting of Adverse Events
STRICTA guidelines specify the need for adverse event reporting. The majority of adverse events were mild subcutaneous hemorrhage, and a tingling sensation. All participants recovered fully from adverse events. Six trials gave the numbers and type of adverse events. One trial (Mohsen. et al. 2013) did not mention the adverse events. More details are in Table 7.
Table 7. Reporting of Adverse Events.
|Clinical trial||Events reporting|
|Frantisek et al .2018||One mild and common adverse event. Facial hematoma resolved within 2 days.|
|Li et al. 2012||Subcutaneous haemorrhage; Subcutaneous hematoma; Subcutaneous ecchymosis; Leg weakness|
|Wang et al. 2015||Dizziness: RA,4; SA3. Bruising: RA,3; SA 1. Pain: RA 3; SA 2. Cold and sweaty: RA 8; SA 5. Tingling: RA 11; SA 1. Recurrent headache: RA 7; SA 2. Muscle spasm in the calf: RA 1; SA 0.|
|Zhao et al. 2018||Tingling sensation: TA 3; SA 0. Swelling of the left ankle: A 1; RA 0. Subcutaneous haemorrhage: TA 1; SA|
|Mohsen et al. 2013||N/A|
|Yang et al. 2011|
Ecchymosis, local paresthesia: 6% TA
Paresthesia, Fatigue, dizziness, somnolence, nausea: 66% medication control group.
|Wang et al. 2011||Subcutaneous haemorrhage: 3. Discomfort in the scalp: 1. Fatigue: TA 1. Fatigue and faintness: Control group:5. Weight gain: control group:2. The side effect of flunarizine.|
5.3. Acupuncture Needling Details
STRICTA suggests that for an RCT in Acupuncture to be valid, it must include needling details. Three of the seven trials conducted gave full marks for the reporting of needling details (Musil et al. 2018; Wang et al. 2015; Wang et al. 2011; In one trial (Li et al. 2012) the needling details scored 6. Two trials (Zhao et al. 2017; Yang et al. 2011) scored five for needling information and should not be classed as high quality. However, because they have achieved more than half of the needling points, they are still considered as a quality of the RCTs. One trial (Mohsen et al. 2013) conducted the lowest score of the needling details, which was 4. The validity of these results is questionable; In this instance, high quality should represent all criteria being met. Individual features are in table 8.
Table 8. Acupuncture needling scores. (STRICTA).
|Musil et al. (2018) Czech||Li .et al (2012) China||Wang et al. (2015) Australia||Zhao et al. (2017) China||Mohsen et al. (2013) Iran||Yang et al. (2011) Tai Wan||Wang et al. (2011) China|
|Description of Acupuncture points name used||V||V||V||V||X||V||V|
|Needling technique reported or not||V||V||V||V||V||V||V|
|Depth of needle insertion||V||X||V||X||X||X||V|
|The duration of the Acupuncture session||V||V||V||X||V||V||V|
|Description of the size of needles used /||V||V||V||V||V||X||V|
|The number of points used||V||V||V||V||X||V||V|
|De Qi sensation||V||V||V||V||V||V||V|
Note: V- Yes, X- No.
5.4. Practitioner Background
Three of seven trials (Li et al. 2012; Wang et al. 2015; and Zhao et al. 2018) stated that the practitioners had five years training (a bachelor degree) and at least five years, three years, four years of clinical experience respectively; one trial (Musil et al. 2018) reported the Acupuncturist gained a master’s degree and had 15 years of clinical practice in Acupuncture; One trial (Wang et al. 2011) did not mention the qualification of the Acupuncturist; however, it stated that the Acupuncturists had 20 years of clinical experience. One trial (Yang et al. 2011) mentioned that the Acupuncturists had a license certificate. One trial (Mohsen, F. et al. 2018) did not specify any information about the certification of the Acupuncturists.
5.5. Diagnostic criteria
Six trials (Li et al. 2012; Wang et al. 2015; Zhao et al. 2017; Musil et al. 2018; Wang et al. 2011; Yang et al. 2011) diagnosed the participants according to the standards of the International Headache Society criteria; one trial (Mohsen et al. 2018) was conducted on participants diagnosed with Migraine, but the standard criteria of diagnosis were not given and failed to meet the STRICTA recommendations.
According to STRICTA recommendations, the rationale for treatment is the essential information that must be provided. With the exception of one trial (Mohsen, F. et al. 2018), six trials adequately reported a precise treatment rationale.
5.6. The Points and Meridians used in the Trials
Acupuncture and Electroacupuncture were included in the treatment group. In these trials, Acupuncture points selection, frequency of treatment, sessions and needles retaining times are different. Specific details are in the STRICTA chart in appendix 2. All the points used in the seven trials are in table 9. The most common acupoints of the included trials are Feng chi(GB-20), Shuai gu (GB-8), Tai yang(EX-HN5), Bai hui(GV-20), He gu (LI-4), Qiu xu(GB-40) and Zu san li (ST-36). These acupoints belong to the Shao yang meridian, Du mai vessel, yang Ming meridian and the extraordinary meridian that is used most often for Migraine. Three trials (Musil et al. 2018; Wang et al. 2015; Wang et al. 2011) based on the syndromes of Migraine in Chinese Medicine. Two trials (Li et al. 2012; Zhao et al. 2018) were based on the syndrome differentiation of meridians in the headache region. One trial (Yang et al. 2011) chose the points according to the trigeminal sensory pathway. One trial (Mohsen et al. 2013) mentioned the points selected according to the syndrome’s differentiation of meridian. It did not list the name of the acupoints, therefore, the quality of the trial is questioned. It is interesting to note, Musil et al. 2018 and Wang et al. 2015 selected the same acupoints to treat the migraine disorder according to the diagnosis of Traditional Chinese Medicine syndrome. They selected the acupoints based on the WHO standard.
Table 9. points used in the seven trials
|Clinical Trial||GB||Liv||Lu||Co||St||Sp||Ht||Si||Bl||Kid||Pc||TH||Ren||Du||Extra Point|
|Frantisek, et al. (2018)||8,20.39||2,3||4||36,40||6,9,10||3||12||20,23||Taiyang|
|Li et al (2012) China|
|Wang et al. (2015) Australia||8,20, 39||2, 3||4||36 ,40|
|Zhao et al. (2018) China|
|Mohsen. et al. (2013) Iran||N/A||N/A||N/A||N/A||N/A||N/A||N/A||N/A||N/A||N/A||N/A||N/A||N/A||N/A||N/A|
|Yang et al. (2011) Tai Wan China||20|
|Wang et al. (2011) China|
5.7. Control Group
The control interventions included in RCTs were SA and drug treatment. Also, one of the heterogeneity sources may be regarding different types of drug treatment. (Wang et al. 2011) stated that Flunarizine, a calcium channel antagonist, was used as opposed to (Yang et al. 2011) Topiramate as the prophylactic was used in the control group. Two trials (Frantisek et al. 2018; Wang et al. 2011) conducted standard pharmacological medication (beta-blockers, tricyclic, Topiramate). These variables may be the causes of statistical heterogeneity of the samples. The interpretation of the findings of the review remains challenging. As a result, later researchers may need to provide a clear comparison of intervention vs control in the studies. Which may improve the results. It will also offer suggestions of combined therapy, including Acupuncture in clinical practice.
5.8. Quality of the Evidence
The methodological quality of the included trials was good. The methodological quality scale (Cochrane, Jadad) was used to do a biased assessment. It was focused on randomisation, blinding, sequence generation, allocation concealment, handling of dropouts and withdrawals. However, the evaluation was restrictive. It gave the comparison between Acupuncture and medication control groups in two trials (Musil et al. 2018; Yang et al. 2011); the patients were unblinded. In all the trials, the Acupuncturists were not blinded. In the Acupuncture field, it is impossible to make the Acupuncturist blinded, so a bias could not be ruled out. Blinding in comparison with drug treatment could be achieved by double-dummy designs (Acupuncture plus drug placebo vs drug plus Sham Acupuncture) as in the trial by Wang et al. 2011, which was the only study that had double-dummy design blinding.
Li et al. (2012), in this trial, the participants were divided to 4 groups, three true Acupuncture groups (which were based on Shao yang specific, Shao yang nonspecific, yang Ming specific) and one Sham Acupuncture group. It also used electronic stimulation in all groups to blind the patients. In the (Li et al. 2012) trial, the contrast was between three true Acupuncture groups and Sham Acupuncture. There were no relevant differences between the three true Acupuncture groups. There was a significant reduction in the number of days with Migraine in all Acupuncture groups compared with Sham Acupuncture during week 13-16. The same points applied to everyone according to meridian syndromes; it may be not practical according to Chinese Medicine. Some flexible points need taking into account. The body diagnosis, tongue and pulse diagnosis may consider individual treatment.
Mohsen et al. (2013), the quality of the trial is poor and questioned. It is not only scored the lowest point with Cochrane, Jadad, but it also failed with the CASP Checklist (appendix 1). In this trial, the authors conducted how to do the clinical experiment, however, it is lack of the evidence; they did not give the Baseline sociodemographic characteristics of the participants, the results of the outcome, not considering the critical clinic outcomes (drop out the number, adverse events). The reader also does not know if all the participants were treated equally or not? The reader would doubt whether the conclusion is applicable in clinical practice
5.9 Limitation of this Study
There are a few limitations of this CLR. Firstly, one of the main limitations is the heterogeneities of these studies. Some trials were using true Acupuncture or Electro-Acupuncture, compared to Sham Acupuncture and a waiting list; or others were using Acupuncture versus medication, and other trials used Acupuncture combined with placebo versus Medicine combined with Sham Acupuncture.
Secondary, the limitation of this review was the inclusion of studies only published in English, other languages, especially Chinese studies, may have been included for consideration. Thirdly, the data gathered for analysis is dominated by the TCM approach to Chinese Medicine. Therefore, the Classical Chinese medical procedure cannot be observed.
Finally, the limitation is the sample sizes; two trials of individual trials included in this study were small, with less than 40 participants in each arm.
Overall, the reviewed studies were of relatively high RCT standard. Given the limited benefits and the adverse reaction of pharmacological treatment of migraines, this review demonstrated that Acupuncture could be an effective and safe form of therapy for prophylaxis of migraines. Data from 7 RCTs included in this review showed that Acupuncture was more effective in reducing the frequency of migraine attacks and the number of migraine days, compared with medication. Moreover, Acupuncture seemed to have higher effective rate compared to sham and drug treatment. However, the quality of evidence of the included trials is variable; the frequency and period of treatments are variable in the seven trials. The designs and reports should be improved in future clinical studies.
TCM pathogenesis of migraine related to complex exogenous factors, internal injury, external pathogenic, and emotions leading to qi stagnation, blood stasis and Phlegm (Flaws 1990). Li and Bi (2013) stated that Shao yang acupoints are widely used to treat migraine. In the seven trials, the practitioners treated the patients either according to the meridian differentiation or syndrome differentiation. Tongue, pulses and body diagnosis considered essential to the Acupuncture treatment. However, none of the trials included these patterns in the procedure.
Furthermore, none of the trials mentioned the direction, and angle of the needle and only reported the depth of the needling. Zhong and Ryan (2012); Fan et al. (2011) stated that the direction, angle and depth of Acupuncture affected the efficacy of Acupuncture analgesia. In all the trials Ashi points were used; they also did not state the location of these points, all dependent on the Acupuncturists’ experience. Improving the efficacy of the Acupuncture in the future, the direction, angle, depth and other Acupuncture factors of selected acupoints should be optimised.
The RCT is a Western method of research, grounded in clinical science. In contrast, Acupuncture is a traditional, ancient art. It may be that Acupuncture will never be accurately assessed in Western society because of the differences in culture, technique, and theory. The standardisation of Acupuncture protocols would be much helpful to improve the methodological quality of Acupuncture studies of Migraine. These may include the size of the trials which could be more homogenous in numbers of patients, large-scale, well-designed, controlled trials and a proper TCM diagnosis to include tongue and pulse diagnosis and adequate reporting of Acupuncture protocols should lead to more rigorous trials and reliable conclusions.
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