Response to Cox-North's Comments on “A Novel Approach to Evaluate TCM Treatment Outcomes Using Pattern Identification”

Dear Editor:

The authors thank Dr. Cox-North for her supportive comments on our article, which discussed the use of Traditional Chinese Medicine (TCM) patterns as a potential outcome measure. ¹ The intent of this article was to introduce the methodology used in a pilot clinical trial to differentiate TCM patterns and administer acupuncture to each study participant according to TCM principles. ² TCM pattern differentiation was then extended to its use as an outcome measure. Due to article word limitation, it was not possible to fully report all the details regarding the design and outcomes of this pilot trial. It is our intent to publish another two articles. The first will report on the study design and results of the effect of acupuncture on the primary outcome disease measures (alanine aminotransferase [ALT] levels and RNA viral load) as well as the secondary outcome measure (Hepatitis Quality of Life Questionnaire). The second proposed article will review and discuss the TCM patterns identified in this study group and the implications for clinical practice.

Dr. Cox-North queried the low recruitment percentage for the study, to which we would like to respond in detail. In total, 130 people expressed an interest in being a participant in the trial. Of those, 19 applicants did not meet the inclusion criteria (stated in Berle et al., 2010) for the following reasons: liver transplant recipient (n = 2); hepatitis B virus co-infection (n = 1); ALT <57 (n = 13); not meeting age criterion (n = 1), and concurrently receiving combination therapy (n = 2). Another 95 chose not to participate for study design reasons. These were as follows: two treatments per week on specified days was prohibitive (n = 6); not wanting to be in a study where they may be randomized to a control group (n = 7); with the remainder unknown (n = 82). Sixteen (16) eligible participants were recruited into either the treatment or control group, which represents a recruitment rate of approximately 12%, with 25% having a reason for nonparticipation and 63% of the potential participants not giving a reason. While there is a large percentage of participants who chose not to give a reason for nonparticipation, we believe that it is quite possible that the treatment schedule (two acupuncture treatments for 12 weeks) was a large commitment and not feasible for many participants because of logistical reasons.