To provide Traditional Chinese Medicine therapy guideline for migraine, tension-type headache and cluster headache based on systematic reviews.
Neurological physician
Adults (aged ≥18 years) with headache. Pregnant women are not included.
Chinese patent drug, Acupuncture, Acupoint, Tuina.
Clinical efficacy rate
Visual analogue scale (VAS)
Headache frequency
Headache duration
Incidence of adverse reaction
Diagnosis of primary headache refers to the International Classification of Headache Disorders, 2nd Edition (ICHD-II).
Acupuncture (Strength of recommendation: strong, Quality of evidence: low)
Detailed explanations for recommendation: The meta analysis of 18 RCT studies [1] showed that the clinical efficacy rate of acupuncture was superior to the control group in the treatment of migraine (RR=1.17, 95% CI (1.12, 1.22), P<0.00001). The subgroup analysis showed that the clinical efficacy rate of acupuncture was superior to flunarizine (RR=1.18, 95% CI (1.10, 1.26), P<0.00001) and nimodipine (RR=1.18, 95% CI (1.10, 1.26), P<0.00001), respectively.
Tianshu capsule (Strength of recommendation: weak, Quality of evidence: low). Its active ingredients are ligusticum wallichii and rhizoma gastrodiae.
Usage: Take 4 capsules 3 times a day.
Detailed explanations for recommendation: The meta analysis of 10 RCT studies[2] showed that the clinical efficacy rate of tianshu capsule was superior to the control group in the treatment of migraine (OR=4.18, 95% CI (2.93, 5.96)，P<0.0001). The meta analysis of 7 RCT studies[2] showed that there was no statistical difference between tianshu capsule and the control group in the incidence of adverse reactions (OR=2.00, 95% CI (0.95, 4.21), P=0.07).
Chuanxiong chatiao powder (Strength of recommendation: weak, Quality of evidence: very low). Its active ingredients are ligusticum wallichii, angelica dahurica, notopterygium root, Asarum sieboldii, radix sileris, schizonepeta, mint and liquorice.
Usage: Take 1 bag 2 times a day.
Detailed explanations for recommendation: The meta analysis of 34 RCT studies [3] showed that the clinical efficacy rate of chuanxiong chatiao powder was superior to the control group in the treatment of migraine (RR=1.26, 95% CI (1.21, 1.31), P<0.0001). Subgroup analysis showed that the clinical efficacy rate of chuanxiong chatiao powder was superior to flunarizine (RR=1.24, 95% CI (1.15, 1.33), P<0.0001). The meta analysis of 3 RCT studies [3] showed that the effect of chuanxiong chatiao powder was superior to the control group in reducing the headache duration (MD=-0.58, 95% CI (-0.86, -0.29), P<0.00001).
Duliang capsule (Strength of recommendation: weak, Quality of evidence: very low). Its active ingredients are ligusticum wallichii and angelica dahurica.
Usage: Take 3 capsules 3 times a day.
Detailed explanations for recommendation: The meta analysis of 3 RCT studies[4] showed that the clinical efficacy rate of duliang capsule was superior to flunarizine in the treatment of migraine (OR=5.12, 95% CI (1.34, 19.65)，P=0.02).
Toutongning capsule (Strength of recommendation: weak, Quality of evidence: low). Its active ingredients are glabrous greenbrier rhizome, rhizoma gastrodiae, radix polygonum multiflorum preparata, angelica sinensis, radix sileris and medicinal scorpion.
Usage: Take 3 capsules 3 times a day.
Detailed explanations for recommendation: The meta analysis of 7 RCT studies[5] showed that the clinical efficacy rate of toutongning capsule was superior to flunarizine in the treatment of migraine (RR=1.19, 95% CI (1.12, 1.27)，P<0.00001). The meta analysis of 5 RCT studies[5] showed that the incidence of adverse reactions of toutongning capsule was lower than flunarizine in the treatment of migraine (RR=0.51, 95% CI(0.29, 0.90), P=0.02).
Blood-letting (Strength of recommendation: weak, Quality of evidence: low)
Detailed explanations for recommendation: The meta analysis of 11 RCT studies [6] showed that the clinical efficacy rate of blood-letting was superior to the control group (acupuncture/Western medicine) in the treatment of migraine (OR=6.23, 95%CI(4.03,9.63), P<0.00001).
Yangxueqingnao granule (Strength of recommendation: weak, Quality of evidence: low). Its active ingredients are angelica sinensis, ligusticum wallichii, white paeonia, prepared rehmannia root, uncaria, caulis spatholobi, selfheal, semen cassiae, nacre, rhizoma corydalis and asarum.
Usage: Take 1 bag 3 times a day.
Detailed explanations for recommendation: The meta analysis of 8 RCT studies[7] showed that there was no statistical difference between yangxueqingnao granule and flunarizine in the clinical efficacy rate of migraine treatment (RR=1.07，95％CI(1.00, 1.15)，P=0.06).
Acupuncture (Strength of recommendation: strong, Quality of evidence: moderate)
Detailed explanations for recommendation: The meta analysis of 4 RCT studies[8] showed that the clinical efficacy rate of acupuncture was superior to the sham acupuncture group in the treatment of tension type headache within 2 months (RR=1.24, 95% CI (1.02, 1.50), P=0.03), 3-4months (RR=1.24, 95% CI (1.05, 1.46), P=0.009) and 5-6months (RR=1.18, 95% CI (1.12, 1.37), P=0.03), respectively. The meta analysis of 2 RCT studies[8] showed that the effect of acupuncture was superior to the sham acupuncture group in reducing the headache days within 2 months (MD=-1.56, 95% CI (-3.20,-0.10), P=0.04), 3-4months (MD=-1.94, 95% CI (-3.15,-0.72), P=0.002) and 5-6months (MD=-1.57, 95% CI (-2.97,-0.17), P=0.03), respectively.
Tuina(Massage)(Strength of recommendation: strong, Quality of evidence: moderate)
Detailed explanations for recommendation: The meta analysis of 8 RCT studies [9-16] showed that the clinical efficacy rate of tuina was superior to the control group in the treatment of tension type headache (RR=1.27, 95% CI (1.17, 1.37), P<0.00001). The subgroup analysis [12, 15, 16] showed that the clinical efficacy rate of tuina was superior to amitriptyline (RR=1.27, 95% CI (1.21, 1.42), P<0.0001).
Yangxueqingnao granule (Strength of recommendation: weak, Quality of evidence: very low). Its active ingredients are angelica sinensis, ligusticum wallichii, white paeonia, prepared rehmannia root, uncaria, caulis spatholobi, selfheal, semen cassiae, nacre, rhizoma corydalis and asarum.
Usage: Take 1 bag 3 times a day.
Detailed explanations for recommendation: The meta analysis of 6 RCT studies [17] showed that the clinical efficacy rate of yangxueqingnao granule was superior to the control group (Placebo/anti-inflammatory analgesic) in the treatment of tension type headache (OR=8.10, 95% CI (4.73, 13.88), P<0.00001).
Toutongning capsule (Strength of recommendation: weak, Quality of evidence: very low). Its active ingredients are glabrous greenbrier rhizome, rhizoma gastrodiae, radix polygonum multiflorum preparata, angelica sinensis, radix sileris and medicinal scorpion.
Usage: Take 3 capsules 3 times a day.
Detailed explanations for recommendation: The meta analysis of 7 RCT studies[18-24] showed that the clinical efficacy rate of toutongning capsule was superior to Western medicine in the treatment of tension type headache (RR=1.31, 95% CI (1.22, 1.41), P<0.00001). The meta analysis of 2 RCT studies[18,19] showed that the effect of toutongning capsule was superior to flunarizine in reducing the headache duration (SMD=-1.21, 95% CI (-1.51, -0.91), P<0.00001). The meta analysis of 3 RCT studies[18,19,22] showed that the effect of toutongning capsule was superior to flunarizine in reducing the degree of headache (VAS) (SMD=-1.19,95% CI (-1.44, -0.93)，P<0.00001). The meta analysis of 2 RCT studies [18,22] showed that the effect of toutongning capsule was superior to flunarizine in reducing the headache frequency (SMD=-1.54, 95% CI(-1.91, -1.16), P<0.00001).
Acupoint injection (Strength of recommendation: None, Quality of evidence: very low)
Detailed explanations for recommendation: One RCT study[25] showed that there was no statistical difference between acupoint injection with lidocaine and oral prednisone in the clinical efficacy rate of tension type headache (RR=1.10，95%CI(0.83, 1.47)，P=0.08). The other one RCT study[26] showed that the clinical efficacy rate of acupoint injection with lidocaine was superior to acupoint injection with normal saline in the treatment of tension type headache (RR=1.40，95%CI(1.01, 1.94)，P=0.04).
Acupuncture (Strength of recommendation: weak, Quality of evidence: low)
Detailed explanations for recommendation: The meta analysis of 20 RCT studies[27-46] showed that the clinical efficacy rate of acupuncture was superior to carbamazepine in the treatment of cluster headache (RR=1.15, 95%CI(1.08, 1.22)，P<0.0001). The meta analysis of 2 RCT studies[28,34] showed that the effect of acupuncture was superior to the control group in reducing the headache frequency (SMD=-0.41，95%CI(-0.77, -0.05)，P=0.02).
Toutongning capsule (Strength of recommendation: weak, Quality of evidence: very low). Its active ingredients are glabrous greenbrier rhizome, rhizoma gastrodiae, radix polygonum multiflorum preparata, angelica sinensis, radix sileris and medicinal scorpion.
Usage: Take 3 capsules 3 times a day.
Detailed explanations for recommendation: The meta analysis of 2 RCT studies [47,48] showed that there was no statistical difference between toutongning capsule and carbamazepine in the clinical efficacy rate of cluster headache treatment (RR=1.03, 95% CI(0.93, 1.14), P=0.55).
Tianma injection (Strength of recommendation: None, Quality of evidence: very low). Its active ingredient is rhizoma gastrodiae.
Usage: Intramuscular injection of 2-4ml per time, l-2 times per day; Acupoint injection of 1ml per time, 1 time per day.
Detailed explanations for recommendation: The meta analysis of 2 RCT studies[49-50] showed that there was no statistical difference between tianma injection and the placebo in the clinical efficacy rate of cluster headache (RR=0.91，95%CI(0.57, 1.43)，P=0.68).
This research was funded by State Administration of Traditional Chinese Medicine (Standardization project, No. SATCM-2015-183).
In the interest of full disclosure, we have adopted the policy of revealing relationships workgroup members have with companies that sell products or services that are relevant to this topic. Workgroup members are required to disclose potential conflicts of interest by completing the Conflict of Interest Form. It should not be assumed that these financial interests will have an adverse impact on the content, but they are noted here to fully inform readers.
The guideline is reviewed using the Appraisal of Guidelines for Research and Evaluation Ⅱ (AGREEⅡ) as the evaluation tool (Scope and purpose: 79%, Stakeholder involvement: 78%, Rigour of development: 78%, Clarity of presentation: 71%, Applicability: 70%, Editorial independence: 81%). The reviewers consist of a multidisciplinary group of individuals (include doctors of Traditional Chinese medicine, nurses, methodologist, etc.). The guideline is adjusted by consensus of these reviewers and approved by China Association of Chinese Medicine.
Potential Benefits
A priority aim and benefit of implementing the recommendations in this guideline would be to improve the percentage of individuals who are able to meet their treatment goal of improving the headache condition.
The guideline provides therapies for primary headache disorders on the basis of systematic reviews. It gives more alternatives options for doctors/ patients to choose the suitable treatment.
Traditional Chinese medicine therapy has good safety. Clinical studies have not reported serious adverse reactions. Using the treatment of Traditional Chinese medicine therapy can reduce the drug dependence in the long-term use.
The guideline would guide and standardize clinical rational use of traditional Chinese medicine and reduce excessive differences in the use of traditional Chinese medicine for primary headache disorders.
Potential Harms
The use of Traditional Chinese Medicine, especially acupuncture and tuina need professionals to handle.
The guideline object are adults(aged≥18) with headache. Juveniles and pregnant women are not included.
The guideline will be published by China association of Chinese medicine. We will spread it through training and academic communication. We will promote the diffusion by developing the guideline into Chinese and English.
We will check the implementation of the guideline and update the guideline according to the feedback.
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