Grain Moxibustion Treatment on Insomnia: a Randomized Controlled Trial

Обзор

This trial intends to observe the clinical efficacy and safety of grain moxibustion at Baihui(GV20), Xinshu(BL15) and Pishu(BL20) in the treatment of insomnia.

Подробное описание

Insomnia is one of the most common sleep disorders. The main symptoms are difficulty in falling asleep, decreased sleep quality and sleep time, and affect the normal work, study and life during the day.

Acupuncture has a good clinical effect on insomnia, but most of the treatment methods are acupuncture or electroacupuncture. Moxibustion therapy, as one of the main components of the therapy, has the advantages of simple operation, wide acceptance, which is suitable for a wide range of promotion and application.At present, the trials of moxibustion in the treatment of insomnia mainly focus on mild moxibustion. The number of studies is small, and the research is designed insufficiently, so it is difficult to draw a positive conclusion, and needs to be further confirmed by rigorous designed experiments. In addition, grain moxibustion, which is widely used in clinic, has the advantages of more convenient operation, short treatment time and strong permeability. However, its efficacy and safety in the treatment of insomnia are still unclear, so it is necessary to carry out a randomized controlled trial to confirm it.

One hundred and two eligible patients will be randomly assigned to one of 3 groups: grain moxibustion group, sham grain moxibustion group and wait-list control group. Treatment will be given 3 times per week for 4 weeks. The primary outcome is the Pittsburgh Sleep Quality Index (PSQI). The secondary outcomes are changes of PSQI scores from baseline to 8 week follow-up, sleep monitoring of bracelet, Athens Insomnia Scale（AIS）, Generalized Anxiety Disorder Scale-7 (GAD-7), Patient Health Questionnaire-9 (PHQ-9) and recurrence observation during the follow-up period. Daily dose of patients' estazolam will be recorded in the dairy. All adverse effects will be assessed by the Treatment Emergent Symptom Scale (TESS). Outcomes will be evaluated at baseline, 4 weeks post-treatment, as well as at 8 week and 12 week follow-up.

This trial intends to observe the clinical efficacy and safety of grain moxibustion at Baihui(GV20), Xinshu(BL15) and Pishu(BL20) in the treatment of insomnia, which will provide an experimental basis for the treatment of insomnia with grain moxibustion and lay the foundation for the promotion and application of moxibustion in the future.

Вмешательства

• Устройство Grain moxibustion
  Take Baihui(GV20), apply vaseline on the acupoint, knead moxa villi into grain size, put it on GV20, and ignite it with incense. When the patient feels burning or a little pain, put out moxa with gauze and keep for 10 seconds, so as to ensure enough heat to be penetrated into the acupoint. There are 3 cones for the first six times and 5 cones for the last six times . After the treatment of GV20, the patient will be in prone position. Select bilateral Xinshu(BL15) and Pishu(BL20) and operate the
• Устройство Sham grain moxibustion
  Take Baihui(GV20), apply vaseline on the acupoint, knead moxa villi into grain size, put it on GV20, and ignite it with incense. When the moxa burns to half （the patient hasn't feel hot or feel a little hot）, take the moxa away with tweezers. There are 3 cones for the first six times and 5 cones for the last six times . After the treatment of GV20, the patient will be in prone position. Select bilateral Xinshu(BL15) and Pishu(BL20) and operate the same as that of GV20. 3 times a week, 12 times i
• Другое Standard care
  Participants in the wait-list control with severe sleep disorders will be allowed to take the sedative-hypnotic drug eszopiclone 0.5-2mg orally (Sinopharm approval H31021534, Shanghai Shangyao Xinyi Pharmaceutical Co., Ltd.). And after waiting for 12 weeks, these patients will be treated with the same grain moxibustion as the grain moxibustion group.

Первичные конечные точки

• Changes of Pittsburgh Sleep Quality Index (PSQI) [Срок оценки: Baseline and week 4]

Вторичные конечные точки (7)

• Changes of PSQI scores [Срок оценки: Baseline and week 12]
• Sleep monitoring of bracelet [Срок оценки: Week 12]
• Changes of Athens Insomnia Scale(AIS) [Срок оценки: Baseline and week 12]
• Changes of Generalized Anxiety Disorder Scale-7(GAD-7) [Срок оценки: Baseline and week 12]
• Changes of Patient Health Questionnaire-9 (PHQ-9) [Срок оценки: Baseline and week 12]
• Recurrence observation during the follow-up period [Срок оценки: Week 12]
• Dose dairy [Срок оценки: 12 weeks]

Критерии участия

Критерии включения

• Meet the diagnostic criteria of insomnia;
• TCM syndrome differentiation belongs to deficiency of both heart and spleen;
• Male or female participants aged 18-75;
• Participants whose PSQI score is 5-15;
• The course of disease is more than 3 months;
• Participants who voluntarily agree with the investigation and sign a written informed consent form for the clinical trial.

Критерии исключения

• Participants with mental retardation;
• Participants with serious cardiovascular diseases, liver, kidney and hematopoietic system diseases;
• Insomnia is caused by nervous system diseases (such as stroke, Parkinson's disease) or mental disorders (including depression or anxiety);
• Female participants who is pregnant or lactating;
• Participants with diabetes and sensory dysfunction.
• Participants with skin diseases of acupoints;
• Taking sedative hypnotics (including barbiturates, benzodiazepines, tranquilizers, diphenylmethane, etc) and other insomnia related drugs within 2 weeks before the trial;
• Participants with dependence on sleeping drugs;
• Participants suffering from malignant tumor, sequelae of severe cerebral apoplexy, organ failure and other major diseases that affect insomnia and therapeutic effect.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Китай · 2 центра

• Shanghai Institute of Acupuncture, Moxibustion and Meridian — Шанхай
• Shanghai Institute of Acupuncture, Moxibustion and Meridian — Шанхай

Идентификаторы

NCT: NCT04980703 · ZYS20210601

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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