Traditional Chinese medicine: Evidence and challenges in fatigue clinical research

The increasing popularity of traditional Chinese medicine (TCM) therapies as health care options warrants thorough examination of the efficacy and safety evidence around these therapies. This thesis explores the intersection of TCM and fatigue using two rigorous methodologies: systematic reviews (SRs) and a randomized controlled clinical trial (RCT). In order to inform the development of an RCT of acupuncture for infectious mononucleosis (mono), a common condition with no known cure, characterized by profound fatigue, we examined the literature on TCM treatment of mono as well as another fatigue condition, idiopathic chronic fatigue (ICF). Additionally, we investigated the literature on the safety of pediatric acupuncture.

SRs of TCM efficacy in mono and ICF determined that although clinical trials exist, methodological flaws compromised their validity. In particular, studies published as RCTs were found to lack proper randomization. Inclusion of these studies in the SRs would have been inappropriate and demonstrates the importance of verifying RCT methods.

We also present the results of the first known SR of pediatric acupuncture safety. This review was comprehensive, including a large number of databases and publications in any language. Synthesis of the results from those studies that included a denominator produced mild adverse event estimates of 16.3/100 (95% CI 11.2–21.5) per patient, for RCTs, and 6.3/100 (95% CI 4.9–7.7) per patient, for cohort studies, with a combined estimate of 7.8/100 (95% CI 6.4–9.2) per patient.

We developed and conducted an RCT of acupuncture for mono, although limitations to recruitment resulted in the enrolment of only three participants. The primary result of the small sample size was to restrict the determination of treatment effect, however, successful implementation of other elements is informative to further research in this area. In addition, we determined the local 5-year Monospot positive incidence rate to be 1.11/1000 (95% CI 0.95–3.2) for all ages and 5.46/1000 (95% CI 0.89–10.0) for the 15-25 year old group.

This dissertation examined the evidence around TCM and fatigue and provides recommendations that are aimed at increasing the value of research and the safety and efficacy of practice in this area.