Pilot Quasi-Randomized Controlled Study of Herbal Medicine Hochuekkito as an Adjunct to Conventional Treatment for Progressed Pulmonary Mycobacterium avium Complex Disease

Abstract

IntroductionHochuekkito, a traditional herbal medicine, is occasionally prescribed in Japan to treat patients with a poor general condition. We aimed to examine whether this medicine was beneficial and tolerable for patients with progressed pulmonary Mycobacterium avium complex (MAC) disease.MethodsThis pilot open-label quasi-randomized controlled trial enrolled 18 patients with progressed pulmonary MAC disease who had initiated antimycobacterial treatment over one year ago but were persistently culture-positive or intolerant. All patients continued their baseline treatment regimens with (n = 9) or without (n = 9) oral Hochuekkito for 24 weeks.ResultsBaseline characteristics were generally similar between the groups. Most patients were elderly (median age 70 years), female, had a low body mass index (<20 kg/m2), and a long-term disease duration (median approximately 8 years). After the 24-week treatment period, no patient achieved sputum conversion. Although the number of colonies in sputum tended to increase in the control group, it generally remained stable in the Hochuekkito group. Radiological disease control was frequently observed in the Hochuekkito group than the control group (8/9 vs. 3/9; p = 0.05). Patients in the Hochuekkito group tended to experience increase in body weight and serum albumin level compared with those in the control group (median body weight change: +0.4 kg vs. −0.8 kg; median albumin change: +0.2 g/dl vs. ±0.0 g/dl). No severe adverse events occurred.ConclusionsHochuekkito could be an effective, feasible adjunct to conventional therapy for patients with progressed pulmonary MAC disease. Future study is needed to explore this possibility.Trial RegistrationUMIN Clinical Trials Registry UMIN000009920

Clinical and Basic Studies on Therapeutic Efficacy of Herbal Medicines against Mycobacterial Infections

“…Hochuekkito (Bu Zhong Yi Qi Tang) (10 herbs including Daucus carota , Astragalus membranaceus , Atractylodes lancea , Bupleurum falcatum , and Angelica acutilob ), is occasionally used in Japan for the control of a weak constitution, physical weariness, anorexia, and gastrointestinal hypomotility. A recent randomized controlled trial enrolling 18 patients with an advanced stages of MAC disease revealed the significant therapeutic efficacy of hochuekkito [50]. In this study, it was found that hochuekkito effectively blocked the increase in bacterial loads in the sputum, accompanied by radiological and nutritional improvements, during 24-week treatment in combination with anti-MAC antimicrobial chemotherapy [50].…”

“…A recent randomized controlled trial enrolling 18 patients with an advanced stages of MAC disease revealed the significant therapeutic efficacy of hochuekkito [50]. In this study, it was found that hochuekkito effectively blocked the increase in bacterial loads in the sputum, accompanied by radiological and nutritional improvements, during 24-week treatment in combination with anti-MAC antimicrobial chemotherapy [50].…”

Effects of Hochuekkito combined with pulmonary rehabilitation in patients with chronic obstructive pulmonary disease

“…They also showed that body weight increased from baseline to the end of the trial in the TJ-41 group, but remained unchanged in the control group. Compared to the control group, patients with Mycobacterium avium complex disease showed increased body weight and serum albumin levels when treated with TJ-41 ( 26 ). In the present study, body weight and %IBW in Group A were significantly increased after 3 months of treatment, but not in Group B.…”

Estimated incidence of adverse reactions to Kampo medicines in randomized controlled clinical trials

“…Pseudoaldosteronism by shakuyakukanzoto was observed during 2 weeks after the start of treatment , but no ADR to shakuyakukanzoto were observed in longer treatment periods such as 4 weeks or 16 weeks . In addition, no ADR were reported for hochuekkito containing 1.5 g/day licorice, given for 24 weeks . As a result, pseudoaldosteronism by licorice is considered to depend on more than only the treatment period.…”