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. 2016 Jun 28;2016(6):CD001218. doi: 10.1002/14651858.CD001218.pub3

Li 2012.

Methods Blinding: participants, outcome ‘assessors’, statisticians
Dropout/withdrawals: 34/476 dropouts + 4 participants excluded post‐randomisation, ITT analysis
Observation period: 4 weeks baseline, 4 weeks treatment, follow‐up weeks 5‐8 and weeks 13‐16 after randomisation
Acupuncturists' assessment: GA completely different/20% ‐ YF similarly/70%
Participants Number of participants included/analysed: 480/476
Condition: migraine with or without aura (IHS second edition)
Demographics: mean age 37 (SD 12) years, 83% female
Setting: 9 hospital departments in China
Time since onset of headaches: mean 98 months
Interventions Acupuncture points (3 treatment groups): group 1) Shaoyang‐specific
acupuncture at TE5, GB34, GB40, GB20; group 2) Shaoyang nonspecific acupuncture with TE19, TE8, GB33, GB42; group 3) Yangming‐specific acupuncture with ST8, LI6, ST36, ST42; in all groups, point selection for a participant was not changed over treatment sessions. Acupuncture was applied unilaterally, alternating between the left and right sides. Auxiliary points: 2 mm lateral to every acupoint or non‐acupoint and punctured to a depth of 2 mm without manual stimulation. Transcutaneous electric acupoint stimulation (HANS: Han's acupoint nerve stimulator, HANS‐200, made in Nanjing, China) at every acupoint or non‐acupoint after needle insertion
Information on acupuncturists: specialized acupuncturists who had at least 5 years’ training and five years’ experience; number not reported
DeChi achieved?: yes
Number of treatment sessions: 20
Frequency of treatment sessions: 5/week
Control intervention: sham acupuncture on the points below with manipulation: i) in the medial arm on the anterior border of the insertion of the deltoid muscle at the junction of deltoid and biceps muscles; ii) the edge of tibia 1‐2 cm lateral to the ST36 horizontally; iii) half between the tip of the elbow and the axilla; iv) ulnar side, half between epicondylus medialis of the humerus and ulnar side of the wrist. Auxiliary points: 2 mm lateral to every acupoint or non‐acupoint and punctured to a depth of 2 mm without manual stimulation. Transcutaneous electric acupoint stimulation (HANS: Han's acupoint nerve stimulator, HANS‐200, made in Nanjing, China) is used for electro‐acupuncture stimulation at every acupoint or non‐acupoint after needle insertion. DeChi not sought
Outcomes Method for outcome measurement: diary, questionnaire
Primary outcome: number of migraine days in weeks 5‐8
Other outcomes: migraine attacks, intensity of migraine, intensity of pain, medication intake, Migraine Specific Quality of Life Questionnaire
Notes Data for migraine days, attack frequency, intensity and response in weeks 5‐8 and weeks 13‐16 used for meta‐analysis in this review were obtained from individual patient data re‐analysis within the Acupuncture Trialists' Collaboration (see section Data collection and analysis)
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk “The randomisation sequence (blocked, stratified for centres) was generated by use of the randomisation module of the synthesized management platform of the Chengdu Good Clinical Practice Centre (block length 12, unknown to centres).”
Allocation concealment (selection bias) Low risk “randomisation was performed by the National Clinical Trial Center of Chinese Medicine, Chengdu Good Clinical Practice Center. Central randomisation was performed by text messages sent by the investigator or by use of a website and email confirmation.”
Blinding (performance bias and detection bias) 
 All outcomes Low risk “Patients, outcome assessors and statisticians were blinded as to randomisation. Patients were informed that they would receive one of four types of acupuncture treatment, three of which used traditional Chinese acupuncture theories and one which was based on modern acupuncture theory.”
Incomplete outcome data (attrition bias) 
 All outcomes up to 3 month after randomisation Low risk 34/476 dropouts + 4 participants excluded post‐randomisation. Number and reasons for dropout similar in the four groups, ITT analysis
Incomplete follow‐up outcome data (attrition bias) 
 All outcomes later than 3 months after randomisation Low risk See above
Selective reporting (reporting bias) Low risk Detailed reporting of findings for main outcomes; pain medication use not reported