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儿童慢性哮喘与脊椎按摩疗法:一项前瞻性临床系列研究及随机临床试验初步研究

Chronic pediatric asthma and chiropractic spinal manipulation: a prospective clinical series and randomized clinical pilot study.

作者信息

Bronfort G, Evans R L, Kubic P, Filkin P

机构信息

Wolfe-Harris Center for Clinical Studies, Northwestern Health Sciences University, Bloomington, MN 55431, USA.

出版信息

J Manipulative Physiol Ther. 2001 Jul-Aug;24(6):369-77. doi: 10.1067/mmt.2001.116417.

Abstract

OBJECTIVES

The first objective was to determine if chiropractic spinal manipulative therapy (SMT) in addition to optimal medical management resulted in clinically important changes in asthma-related outcomes in children. The second objective was to assess the feasibility of conducting a full-scale, randomized clinical trial in terms of recruitment, evaluation, treatment, and ability to deliver a sham SMT procedure.

STUDY DESIGN

Prospective clinical case series combined with an observer-blinded, pilot randomized clinical trial with a 1-year follow-up period.

SETTING

Primary contact, college outpatient clinic, and a pediatric hospital.

PATIENTS

A total of 36 patients aged 6 to 17 years with mild and moderate persistent asthma were admitted to the study.

OUTCOME MEASURES

Pulmonary function tests; patient- and parent- or guardian-rated asthma-specific quality of life, asthma severity, and improvement; am and pm peak expiratory flow rates; and diary-based day and nighttime symptoms.

INTERVENTIONS

Twenty chiropractic treatment sessions were scheduled during the 3-month intervention phase. Patients were randomly assigned to receive either active SMT or sham SMT in addition to their standardized ongoing medical management.

RESULTS

It is possible to blind the participants to the nature of the SMT intervention, and a full-scale trial with the described design is feasible to conduct. At the end of the 12-week intervention phase, objective lung function tests and patient-rated day and nighttime symptoms based on diary recordings showed little or no change. Of the patient-rated measures, a reduction of approximately 20% in beta(2) bronchodilator use was seen (P =.10). The quality of life scores improved by 10% to 28% (P <.01), with the activity scale showing the most change. Asthma severity ratings showed a reduction of 39% (P <.001), and there was an overall improvement rating corresponding to 50% to 75%. The pulmonologist-rated improvement was small. Similarly, the improvements in parent- or guardian-rated outcomes were mostly small and not statistically significant. The changes in patient-rated severity and the improvement rating remained unchanged at 12-month posttreatment follow-up as assessed by a brief postal questionnaire.

CONCLUSION

After 3 months of combining chiropractic SMT with optimal medical management for pediatric asthma, the children rated their quality of life substantially higher and their asthma severity substantially lower. These improvements were maintained at the 1-year follow-up assessment. There were no important changes in lung function or hyperresponsiveness at any time. The observed improvements are unlikely as a result of the specific effects of chiropractic SMT alone, but other aspects of the clinical encounter that should not be dismissed readily. Further research is needed to assess which components of the chiropractic encounter are responsible for important improvements in patient-oriented outcomes so that they may be incorporated into the care of all patients with asthma.

摘要

目的

第一个目的是确定整脊脊柱手法治疗(SMT)联合最佳药物治疗是否会使儿童哮喘相关结局产生具有临床意义的变化。第二个目的是从招募、评估、治疗以及实施假SMT程序的能力方面评估开展一项全面的随机临床试验的可行性。

研究设计

前瞻性临床病例系列研究,结合一项为期1年随访期的观察者盲法试点随机临床试验。

研究地点

初级保健机构、大学门诊诊所和一家儿童医院。

患者

共36名年龄在6至17岁的轻度和中度持续性哮喘患者纳入本研究。

观察指标

肺功能测试;患者、家长或监护人评定的哮喘特异性生活质量、哮喘严重程度及改善情况;上午和下午的呼气峰值流速;以及基于日记记录的白天和夜间症状。

干预措施

在3个月的干预阶段安排20次整脊治疗疗程。患者在接受标准化持续药物治疗的基础上,被随机分配接受主动SMT或假SMT。

结果

可以使参与者对SMT干预的性质不知情,且按所描述设计开展全面试验是可行的。在12周干预阶段结束时,客观肺功能测试以及基于日记记录的患者评定的白天和夜间症状几乎没有变化。在患者评定的指标中,β₂受体激动剂的使用量减少了约20%(P = 0.10)。生活质量评分提高了10%至28%(P < 0.01),其中活动量表变化最大。哮喘严重程度评分降低了39%(P < 0.001),总体改善评分为50%至75%。肺科医生评定的改善程度较小。同样,家长或监护人评定的结局改善大多较小且无统计学意义。通过简短的邮寄问卷评估,在治疗后12个月随访时,患者评定的严重程度变化和改善评分保持不变。

结论

在将整脊SMT与儿童哮喘的最佳药物治疗相结合3个月后,儿童对其生活质量的评定显著提高,对哮喘严重程度的评定显著降低。这些改善在1年随访评估中得以维持。在任何时候,肺功能或高反应性均无重要变化。观察到的改善不太可能仅是整脊SMT的特定作用所致,而是临床接触中其他不应轻易忽视的方面导致的。需要进一步研究以评估整脊治疗过程中的哪些组成部分对以患者为导向的结局的重要改善起作用,以便将其纳入所有哮喘患者的治疗中。

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