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081059

Evidence Reports of Kampo Treatment 2010
Task Force for Evidence Reports / Clinical Practice Guideline Special Committee for EBM, the Japan Society for Oriental Medicine Reference
Ohnishi M, Hitoshi K, Katoh M, et al. Effect of a Kampo preparation, Byakkokaninjinto, on the pharmacokinetics of ciprofloxacin and tetracycline. Biological & Pharmaceutical Bulletin 2009; 32: 1080–4. CENTRAL ID: CN-00704915, Pubmed ID: 19483319 Objectives
To evaluate the effects of co-administered byakkokaninjinto (白虎加人参湯) on pharmacokinetics and
renal excretion of antibiotics (tetracycline or ciprofloxacin.
Design
Randomized controlled cross-over trial (RCT-cross over).
Setting
Department of Pharmacy and Pharmacokinetics, Aichi Medical University and Faculty of Pharmacy, Meijo
University.
Participants
Twenty healthy male volunteers (aged 23–36, mean 29.3 years).
Intervention
Study 1
Arm 1: oral ciprofloxacin (Ciproxan tablet) 200 mg alone.
Arm 2: oral ciprofloxacin (Ciproxan tablet) 200 mg + byakkokaninjinto (白虎加人参湯) 3 g.
Each subject took Ciproxan immediately after taking byakkokaninjinto (白虎加人参湯) with 180 mL of
water. After a 7-day wash-out period, the treatments were switched.
Study 2
Arm 1: oral tetracycline (Achromycin V capsule) 250 mg alone.
Arm 2: oral tetracycline (Achromycin V capsule) 250 mg + byakkokaninjinto (白虎加人参湯) 3 g.
The dosing and cross-over were performed in the same manner as Study 1.
The number of subjects in each arm is not specified.
Main outcome measures
Plasma and urinary concentrations of tetracycline and ciprofloxacin were measured by HPLC.
Main results
The peak plasma concentration (Cmax) and area under the plasma concentration-time curve (AUC) of
tetracycline and ciprofloxacin were significantly decreased by co-administration of byakkokaninjinto. The
decrease in bioavailability of ciprofloxacin (15%) was smaller compared with that of tetracycline (30%).
The co-administration of byakkokaninjinto significantly decreased urinary excretion rate of tetracycline,
but not that of ciprofloxacin. Byakkokaninjinto had no effect on renal clearance of either antibiotic.
Conclusions
Byakkokaninjinto appears to reduce the absorption of tetracycline and ciprofloxacin.
From Kampo medicine perspective
In this study, it was assumed that byakkokaninjinto was used for treating heat exhaustion and febrile
disease.
10. Safety assessment in the article
11. Abstractor’s comments
This highly suggestive study noted that co-administered byakkokaninjinto may reduce the absorption of tetracyclines and new quinolone agents (e.g., ciprofloxacin). The authors stated that this reduction may be due to the formation of chelates with Ca2+ contained in byakkokaninjinto. There remain some problems in the study design, such as small number of participants, inclusion of male subjects only, and no description of the number of subjects assigned to each arm. Yet the results of this study, if confirmed, mean that the co-administered byakkokaninjinto may delay the cure of infectious diseases, and therefore will have a strong impact on clinical practice. An RCT of byakkokaninjinto in patients with infectious diseases is desirable, but ethical aspects of such a trial must be considered. Alternatively, retrospective studies, including studies with a case-control design, might be of some help. Further studies on this topic are expected. 12. Abstractor and date

Source: http://www.jsom.or.jp/medical/ebm/ere/pdf/090017e.pdf

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