Objectives: To observe the efficacy of napex acupoint thread-embedding combined with metoprolol tartrate tablet for prophylactic treatment of migraine without aura, and to compare its efficacy with simple napex acupoint thread-embedding and simple metoprolol tartrate tablet.
Methods: A total of 105 patients with migraine without aura were randomized into a combination group (35 cases, 5 cases dropped out), a thread-embedding group (35 cases, 4 cases dropped out) and a western medication group (35 cases, 2 cases dropped out). In the thread-embedding group, napex acupoint thread-embedding was applied at bilateral Fengchi (GB 20) and points of 1.5 cun nearby to the lower edge of spinous process of cervical 2. In the western medication group, metoprolol tartrate tablet was given orally, 12.5 mg a time, twice a day. In the combination group, napex acupoint thread-embedding combined with oral metoprolol tartrate tablet was delivered. The treatment of 8 weeks was required in the 3 groups. The days of headache attacks, frequency of headache attacks, headache severity (visual analogue scale [VAS] score) and the migraine specific quality of life questionnaire version 2.1 (MSQ) score were observed during baseline period (4 weeks before treatment to before treatment), observation period (1-4 weeks and 5-8 weeks in treatment) and follow-up period (1-4 weeks after treatment completion) respectively, the proportions of the days of headache attacks/frequency of headache attacks relieved by 50% were calculated, and the safety was evaluated in the 3 groups.
Results: During the observation period and the follow-up period, the days of headache attacks, frequency of headache attacks and headache VAS scores in the 3 groups were reduced compared with those of the baseline period (P<0.05). During the observation period and the follow-up period, the days of headache attacks and the frequency of headache attacks in the combination group were lower than those in the thread-embedding group and the western medication group (P<0.05); during the observation period (1-4 weeks in treatment), the headache VAS scores in the combination group and the thread-embedding group were lower than that in the western medication group (P<0.05); during the observation period (5-8 weeks in treatment) and the follow-up period, the headache VAS scores in the combination group were lower than those in the thread-embedding group and the western medication group (P<0.05). During the observation period and the follow-up period, the scores of role restriction, role prevention and emotion function of MSQ in the combination group were increased compared with those of the baseline period (P<0.05); during the observation period (5-8 weeks in treatment) and the follow-up period, the role prevention scores of MSQ in the thread-embedding group and the western medication group were increased compared with those of the baseline period (P<0.05); during the follow-up period, the emotion function scores of MSQ in the thread-embedding group and the western medication group were increased compared with those of the baseline period (P<0.05). During the observation period and the follow-up period, the scores of role restriction, role prevention and emotion function of MSQ in the combination group were higher than those in the thread-embedding group and the western medication group (P<0.05). There was no statistical difference in the proportions of the days of headache attacks/frequency of headache attacks relieved by 50% among the 3 groups (P>0.05), and there were no serious adverse reactions in the 3 groups.
Conclusions: Napex acupoint thread-embedding combined with metoprolol tartrate tablet, simple napex acupoint thread-embedding and simple metoprolol tartrate tablet all can reduce the days of headache attacks and the frequency of headache attacks, relieve headache severity and improve the quality of life in patients with migraine without aura. Napex acupoint thread-embedding combined with metoprolol tartrate tablet has a better effect.
目的: 观察枕项部埋线法联合酒石酸美托洛尔片预防性治疗无先兆偏头痛的临床疗效，并与单纯枕项部埋线法、单纯酒石酸美托洛尔片治疗进行比较。方法: 将105例无先兆偏头痛患者随机分为联合组（35例，脱落5例）、埋线组（35例，脱落4例）和西药组（35例，脱落2例）。埋线组予枕项部埋线法（于双侧风池、C2棘突下旁开1.5寸处埋线，每2周1次）治疗，西药组予口服酒石酸美托洛尔片（每次12.5 mg，每日2次）治疗，联合组予枕项部埋线法联合口服酒石酸美托洛尔片治疗，3组均治疗8周。分别于基线期（治疗前4周~治疗前）、观察期（治疗1~4周、治疗5~8周）和随访期（治疗结束后1~4周）观察3组患者头痛发作天数、头痛发作次数、头痛程度［视觉模拟量表（VAS）评分］和偏头痛特异性生活质量问卷2.1版（MSQ）评分，计算3组患者头痛发作天数、发作次数改善50%应答率，并评价安全性。结果: 观察期和随访期，3组患者头痛发作天数、头痛发作次数、头痛VAS评分均较基线期减少（P<0.05）。观察期和随访期，联合组患者头痛发作天数、头痛发作次数少于埋线组和西药组（P<0.05）；观察期（治疗1~4周）联合组和埋线组患者头痛VAS评分低于西药组（P<0.05），观察期（治疗5~8周）及随访期联合组患者头痛VAS评分低于埋线组和西药组（P<0.05）。观察期及随访期，联合组患者MSQ角色限制、角色妨碍、情感功能评分较基线期升高（P<0.05）；观察期（治疗5~8周）及随访期，埋线组和西药组患者MSQ角色妨碍评分较基线期升高（P<0.05）；随访期，埋线组和西药组患者MSQ情感功能评分较基线期升高（P<0.05）。观察期及随访期，联合组患者MSQ角色限制、角色妨碍、情感功能评分高于埋线组和西药组（P<0.05）。3组头痛发作天数、发作次数改善50%应答率比较差异无统计学意义（P>0.05）；3组均未出现严重不良反应。结论: 枕项部埋线法联合口服酒石酸美托洛尔片、单纯枕项部埋线法和单纯口服酒石酸美托洛尔片均可有效减少无先兆偏头痛患者头痛发作天数、发作次数，减轻头痛程度，改善生活质量，枕项部埋线法联合口服酒石酸美托洛尔片疗效更优。.
Keywords: metoprolol tartrate tablet; migraine without aura; napex acupoint thread-embedding; prophylactic treatment; randomized controlled trial (RCT).