Even in studies of adults with cancer, many of the studies done lack adequate controls, or are very small and underpowered to demonstrate efficacy. These aspects of IT make good randomized clinical trials of the biological therapies very challenging Investigations of non-pharmacologic therapies such as massage and acupuncture are hampered by the challenges of finding appropriate placebos, and the difficulty of ensuring a uniform approach between practitioners and from patient to patient.
The whole concept of disease and wellness is different than in Western medicine, and the herbs used have multiple components. Traditional Chinese Medicine (TCM) and other traditional medicine techniques use a very personalized approach that individualizes treatment, using multiple herbs simultaneously, to restore an individual’s well-being rather than focusing more generally on a type of disease. Preclinical and phase I studies are often not done.
Research on IT is complex and usually more difficult than that of conventional therapies, particularly in children with cancer. Only 23% of patients revealed their IT use to their physician despite the importance of discussing all medications used during a phase I trial. In a study of adults enrolled in phase I trials, 52% of patients were using some sort of integrative therapy, and 77% of those were using a pharmacologic form of IT. This fact is striking given that most pediatric oncology patients are participating in clinical trials where concomitant medications and their side effects are important to track and report, and further compounded as many patients increase IT use when upfront therapy fails, a time when many patients are enrolled in studies of investigational agents subject to even closer monitoring. Other studies have documented that most patients and parents do not discuss their use of IT with their physicians, and most pediatric oncologists do not ask about IT use. Since a portion of patients stopped use after diagnosis, this may indicate that physician disapproval influences patients’ discontinuation of IT use. An interesting finding in this study was that 78% of patients informed a physician of their IT use, a number higher than that cited in other studies, though only 16% of the attending pediatric oncologists reacted approvingly. Of note, this study did not include prayer/spiritual healing which may partly explain the low rates. In this study, IT use actually dropped after the cancer diagnosis, with 41% reporting use prior to the diagnosis and only 31% since the diagnosis. Gottschling recently published a population-based survey, covering 457 pediatric oncology patients across Germany and with a high response rate, suggesting that non-users were likely to be represented. Since that review was published there have been a few additional surveys of IT use in pediatric cancer. The analysis reported that IT use was not associated with gender, age, ethnicity, or family income of pediatric patients with cancer. IT was primarily employed by patients to cure or help fight the child’s cancer, to provide symptomatic relief, and to support conventional medicine, such as to relieve toxicities. The most commonly and consistently reported IT modalities were herbal remedies, diets and nutrition, and faith-healing. Additionally, studies report on different patient populations, including multiple different countries, where practices may differ greatly. In the latter case, some respondents might not consider their practices, such as taking vitamins, or spiritual healing, to be “IT” and therefore might under-report. For example, some studies list types of IT in the survey, while others ask open-ended questions regarding use. Some of the inconsistency resulted from different definitions of IT in different studies and different methodology. They found that these prior surveys yielded inconsistent results IT prevalence ranged from 6%–91% in the prior studies (although most were in the range of 20%–60%). published a meta-analysis of all published surveys regarding IT use among pediatric cancer patients. Multiple studies have surveyed the prevalence of IT use among pediatric oncology patients.