Chinese herbs can facilitate sputum culture conversion, promote lesion absorption, and enhance clinical symptoms and quality of life for patients with Mycobacterium abscessus pulmonary disease (MAB-PD). The investigators aimed to evaluate the efficacy of Chinese herbs as adjunct therapy to improve cure rates or reduce recurrence rates during the continuation phase of MAB-PD treatment.
Mycobacterium abscessus pulmonary disease (MAB-PD) is a significant form of non-tuberculous mycobacterial lung infection that clinically presents with symptoms such as cough, sputum production, hemoptysis, low-grade fever, and chest tightness. Current guidelines recommend treatment regimens that are divided into initial and continuation phases. The initial phase involves combination therapy with at least three antibiotics, which can be administered intravenously or orally. In contrast, the continuation phase requires the use of oral or inhaled antibiotics. Guidelines suggest continuing treatment for 12 months after sputum culture negativity, although standard protocols indicate only a 35% cure rate with up to a 40% post-treatment relapse rate. Research has shown that traditional Chinese herbal formulas have broad immunomodulatory effects, which promote sputum culture conversion, lesion absorption, and improvement in clinical symptoms and quality of life for patients with MAB-PD. This study will enroll patients with MAB-PD who have completed initial treatment and will be divided into two independent randomized controlled trials (RCTs) based on sputum M.abscessus culture results. RCT-1 will include patients with persistently positive bacterial cultures receiving Chinese herbal therapy supplemented with the guideline-recommended regimen, with primary endpoints being 52-week cure rates. RCT-2 will include patients with negative bacterial cultures receiving Chinese herbal therapy supplemented with the guideline-recommended regimen, with primary endpoints being 52-week rates of relapse or reinfection. Patients will receive complimentary Chinese herbal medicine. All participants will undergo sputum or bronchoalveolar lavage fluid bacteriological testing, chest imaging, pulmonary function tests, a 6-minute walk test, SF-36, QOL-B, SGRQ, and HADS scales. Additionally, exploratory studies will collect sputum, bronchoalveolar lavage fluid, blood, and stool samples to identify the comprehensive immune profile of MAB-PD and evaluate the intervention advantages of traditional Chinese medicine.
Study Type
INTERVENTIONAL
Allocation
This is an empirical traditional Chinese medicine compound used in the treatment of Mycobacterium abscessus pulmonary disease for a long time
Chinese herbs-I placebo
This is an empirical traditional Chinese medicine compound used in the treatment of Mycobacterium abscessus pulmonary disease during the continuation phase for a long time
Beijing Chest Hospital Affiliated to Capital Medical University
Beijing, China
NOT_YET_RECRUITINGChina-Japan Friendship Hospital
Beijing, China
NOT_YET_RECRUITINGGuangzhou Municipal Hospital of Chest Medicine
Guangdong, China
Clinical cure rate
Measured the change from the Baseline to the end of treatment. The sputum MAB culture was negative on three consecutive occasions, with at least a one-month interval between each, and there were no subsequent positive results.
Time frame: At the end of 52 weeks of treatment
Relapse or reinfection rates
Bacterial relapse is defined as the occurrence of at least two cultures and/or molecular biology tests identifying the same pathogenic M. abscessus strain as the initial infection after completing anti-M. abscessus treatment. When necessary, genotyping techniques may be employed to differentiate between relapse and reinfection. Reinfection refers to the emergence of different pathogenic strains or species in at least two positive cultures following the initiation of treatment.
Time frame: At the end of 52 weeks of treatment
Time to sputum culture conversion
Measured the change from Baseline to the end of treatment
Time frame: From baseline to 52 weeks post-treatment completion
Absorption rate of lung lesions
The lung lesion absorption rate is assessed via chest imaging to evaluate changes in pulmonary infection lesions compared to the baseline at 26 and 52 weeks after enrollment. Patients with more than half of their lesions absorbed are classified as showing significant absorption; those with less than half absorption are considered to have absorption; those with no changes are deemed to show no change; and those with enlarged lesions or new lesions are regarded as demonstrating deterioration. The determination of the lung lesion absorption rate is made by professional radiology experts.
Time frame: Baseline, 26 weeks and 52 weeks
Rate of closure of lung cavities
The lung cavity closure rate is assessed through chest imaging to evaluate changes in lung cavities compared to the baseline at 26 and 52 weeks after enrollment. The clinical criteria for CT changes were as follows: Regarding changes in cavity size, scar healing, block healing, or disappearance were defined as closure. A reduction in cavity size by 1/2 or more was defined as reduction, a reduction in cavity diameter by less than 1/2 was classified as no change, and an increase in the cavity diameter by 1/2 or more was defined as increase. The determination of the lung lesion absorption rate is made by professional radiology experts.
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RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
352
Chinese herbs-II placebo
Anhui Provincial Chest Hospital
Hefei, China
RECRUITINGJiangxi Chest Hospital
Nanchang, China
NOT_YET_RECRUITINGFudan University Affiliated Huashan Hospital
Shanghai, China
NOT_YET_RECRUITINGLonghua Hospital Affiliated Shanghai University of TCM
Shanghai, China
RECRUITINGShanghai Pulmonary Hospital
Shanghai, China
RECRUITINGTime frame: Baseline, 26 weeks and 52 weeks
Pulmonary function tests
Assess the patient's pulmonary function, specifically the changes in FEV1 (L), before treatment, as well as at 26 weeks and 52 weeks post-treatment
Time frame: Baseline, 26 weeks and 52 weeks
6 minute walking test
Measured the change from Baseline to the end of treatment
Time frame: Baseline, 12 weeks, 26 weeks, 40 weeks and 52 weeks
36 - item Short Form (SF - 36)
The 36 - item Short Form (SF - 36) consists of 8 domains, namely physical functioning, role-physical, bodily pain, general health perceptions, vitality, social functioning, role-emotional, and mental health. The SF - 36 scale ranges from 0 to 100 points, where higher scores signify better outcomes. The change from baseline to the end of treatment was measured at the indicated time.
Time frame: Baseline, 12 weeks, 26 weeks, 40 weeks and 52 weeks
Quality of Life Questionnaire for Bronchiectasis (QoL-B)
The Quality of Life Questionnaire for Bronchiectasis (QoL-B) encompasses eight dimensions: physical function, role function, vitality, emotion, social function, treatment effect, health perception, and respiratory symptoms. Each dimension is scored on a scale ranging from 0 to 100, where higher scores signify a better quality of life. The change from baseline to the end of treatment was measured at the indicated time.
Time frame: Baseline, 12 weeks, 26 weeks, 40 weeks and 52 weeks
Saint George's respiratory questionnaire (SGRQ)
The Saint George's Respiratory Questionnaire (SGRQ) scale comprises 50 questions, which assess three aspects: symptoms, activity, and disease impact. The calculation method is a weighted - average algorithm. The score of each item ranges from 0 to 100. The higher the score, the poorer the quality of life; the lower the score, the better the quality of life. The change from the baseline to the end of treatment was measured at the indicated time.
Time frame: Baseline, 12 weeks, 26 weeks, 40 weeks and 52 weeks
Hospital Anxiety and Depression Scale (HADS)
The HADS scale is employed to evaluate patients' anxiety and depression, with a total score ranging from 0 to 42 points. The anxiety sub - scale ranges from 0 to 21 points, and the depression sub - scale also ranges from 0 to 21 points. Higher scores signify a greater risk of anxiety or depression. The change from the baseline to the end of treatment was measured at the specified time.
Time frame: Baseline, 12 weeks, 26 weeks, 40 weeks and 52 weeks