title: A Randomized Controlled Study to Observe the Efficacy of External Treatment With a Traditional Chinese Medicine Herbal Ointment on Malignant Plural Effusion: Outcome Report and Design Review.
abstract: Malignant pleural effusion (MPE) is a common complication in most malignancies. Despite its frequent occurrence, current knowledge of MPE remains limited and the effect of the management is still unsatisfying. Traditional Chinese medicine (TCM) external treatment has unique advantages, such as quicker efficacy and fewer side effects.
  
  
  
  To observe the effects and safety of Kang'ai Xiaoshui ointment (TCM herbal ointment) in MPE.
  
  
  
  This was a placebo-controlled double-blinded randomized study. A total of 80 patients were enrolled, of which 72 were randomized to receive Kang'ai Xiaoshui ointment or placebo at an allocation ratio of 1:1. Kang'ai Xiaoshui ointment or placebo was applied on the thorax wall for 8 hours daily. The intervention lasted 2 weeks. Kang'ai Xiaoshui ointment consisted of Astragalus membranaces （）, Semen pharbitidis （）, Cassia twig （）, Pericarpium arecae （）, Curcuma zedoary （）, Borneol （), and other substances. In both groups, diuresis and drainages were used as needed. Outcomes covered the quantity of pleural effusion evaluation, TCM Symptom Scale, Karnofsky Performance Scale, and safety indicators such as routine blood test, blood biochemistry test, and response table of skin irritation.
  
  
  
  Of 72 patients randomized to receive Kang'ai Xiaoshui ointment or placebo along with symptomatic treatment, the response rate was documented as 42.4% for the treatment group and 25.0% for the placebo group ( P = .138). As for the TCM symptom scale, the treatment group showed improvement in chest distress ( P = .003), fullness and distention ( P = .042), shortness of breath ( P < .001), no statistical significance in palpitation ( P = .237), and pain ( P = .063), whereas the placebo group did not show statistical significance in any of the 5 symptoms. Major adverse events related to the treatment, mainly skin irritation, were distributed equally.
  
  
  
  Kang'ai Xiaoshui ointment showed a potential of reducing MPE, and it could alleviate symptoms of dyspnea. Thus, it may be appropriate as a supplementary intervention for MPE. There were some flaws in the study design. A larger scale and better designed trial is advocated.
authors.affiliation: 1 Beijing University of Chinese Medicine, Beijing, China.|2 China-Japan Friendship Hospital, Beijing, China.
authors.forename: Wu
authors.initials: W
authors.lastname: Feize
authors.affiliation: 2 China-Japan Friendship Hospital, Beijing, China.
authors.forename: Liu
authors.initials: L
authors.lastname: Meng
authors.affiliation: 2 China-Japan Friendship Hospital, Beijing, China.
authors.forename: Lou
authors.initials: L
authors.lastname: Yanni
authors.affiliation: 2 China-Japan Friendship Hospital, Beijing, China.
authors.forename: Li
authors.initials: L
authors.lastname: Yuan
authors.affiliation: 2 China-Japan Friendship Hospital, Beijing, China.
authors.forename: Jia
authors.initials: J
authors.lastname: Liqun
authors.affiliation: 3 Beijing University of Chinese Medicine Third Affiliated Hospital, Beijing, China.
authors.forename: Li
authors.initials: L
authors.lastname: Tong
authors.affiliation: 4 Beijing Hospital of Traditional Chinese Medicine, Beijing, China.
authors.forename: Yang
authors.initials: Y
authors.lastname: Guowang
authors.affiliation: 2 China-Japan Friendship Hospital, Beijing, China.
authors.forename: Cui
authors.initials: C
authors.lastname: Huijuan
authors.affiliation: 2 China-Japan Friendship Hospital, Beijing, China.
authors.forename: Wan
authors.initials: W
authors.lastname: Donggui
authors.affiliation: 2 China-Japan Friendship Hospital, Beijing, China.
authors.forename: Cheng
authors.initials: C
authors.lastname: Zhiqiang
authors.affiliation: 1 Beijing University of Chinese Medicine, Beijing, China.
authors.forename: Zheng
authors.initials: Z
authors.lastname: Lei
mesh_terms: D000368:Aged; D004311:Double-Blind Method; D004365:Drugs, Chinese Herbal / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D008297:Male; D008516:Medicine, Chinese Traditional / Q000379:methods; D008875:Middle Aged; D009824:Ointments / Q000627:therapeutic use*; D016066:Pleural Effusion, Malignant / Q000188:drug therapy*; D016896:Treatment Outcome
chemical_list: D004365:Drugs, Chinese Herbal; D009824:Ointments
keywords: RCT; external treatment; malignant plural effusion; palliative treatment; traditional Chinese medicine