The initial project of the BraveNet practice-based research network involved collection of a one-time questionnaire from about 500 participants at each of our nine clinical sites
. Building on the initial experience of collecting data as a multi-site group, SIMTAP demonstrated our ability to enroll participants and capture outcomes in a prospective longitudinal study, requiring serial follow-up data collection at three time points beyond baseline as well as the ability to collect and process laboratory specimens. The establishment of this functioning practice-based research network in integrative medicine is one of the main accomplishments of this endeavor.
We surpassed the target enrollment of 400, with 409 participants ultimately enrolled. Of these, 88 (21.5%) did not contribute data at the six-week study visit. At 24 weeks, 66% of the enrolled participants were available for follow-up. Chronic pain trials frequently encounter retention issues for a number of reasons, including the nature of the population. It has been suggested that in a typical 12-week, fixed-dose, placebo-controlled trial, a dropout rate of 20%–50% is to be expected
. Our participants received no financial incentives for their participation in the 24-week study and, in fact, were responsible for the cost of their integrative treatments. A recent trial on a three-month yoga intervention versus usual care for chronic back pain randomized 156 patients to the yoga arm
. Of these, 93 (60%) attended at least three of the first six sessions and at least three others. Acknowledging the need to improve retention, we conclude that within the context of chronic pain intervention trials, the practice-based research network is successful in recruiting and retaining patients who contribute data to assess the impact of the interventions on patient-reported outcomes of interest in a usual care (non-efficacy) setting.
Our study demonstrates that an integrative approach to treating chronic pain had a significant impact on patients’ pain as well as on associated symptoms and quality of life. This success was in the context of long-standing chronic pain, with an average duration in our sample of greater than eight years. Whereas conventional medical interventions, such as pharmaceuticals or surgery, generally focus on one outcome, integrative interventions have the potential to affect multiple aspects of health and well-being
. It has been recommended that additional patient-recorded outcome measures are also important to monitor, particularly in studies of chronic pain
. The trends in decreased pain, stress, depression, and fatigue, and improvement in physical quality of life and overall well-being, were consistent over the 24-week duration of the trial and suggest the possibility of sustainable effects of the integrative interventions
. Particularly notable is the decrease in severity of participants’ depression symptoms, given what is known about the challenges of treating chronic pain and depression. In addition, findings on the WPAI survey suggest that the improvements measured in patient-reported outcomes also translated into greater productivity at work. Predictors of response to an integrative medicine approach included years of chronic pain, ethnicity, and baseline BPI interference and SF-12 physical component scores.
We investigated hs-CRP as a general marker of inflammation rather than as a predictor of cardiac risk
[20, 21]. The mean hs-CRP value declined one point, suggesting a trend toward decreased inflammation. In a previous study on musculoskeletal pain conducted at our Minneapolis BraveNet site, 93% of the participants were found to have insufficient levels of 25-hydroxyvitamin D (≤20 ng/mL)
. To further assess the relationship of hypovitaminosis D to pain, we included vitamin D levels in SIMTAP. Our patients presented with baseline vitamin D levels higher than those seen in the prior study and in the average American adult
[21, 23]. This likely reflects awareness among both patients and practitioners of the increasing importance of adequate vitamin D levels. The findings that 70% of SIMTAP participants had values greater than 30 ng/mL and none were deficient at week 12 reflect the serious attention paid to maintaining sufficient vitamin D in integrative medicine practices.
One limitation of this study is the loss to follow-up. Our results describe the outcomes of 252 participants at nine sites who completed all study visits during the 24-week integrative medicine intervention for chronic pain. It could be argued that these completers were somehow different from the noncompleters, skewing the final study results, although this notion is not supported by the sensitivity analysis. The bulk of patients lost failed to return for the first study follow-up at week six. This may represent patients who were “shopping” for a new approach for their chronic pain, visited one of the centers, enrolled in SIMTAP, and then chose not to return for follow-up care. The 252 completers can be considered as being treated “on protocol” for analysis in this prospective non-randomized open-label intervention.
A second limitation is the absence of a control group. It could be argued that the significant benefits we observed in SIMTAP participants may have nothing to do with the integrative intervention per se. Because we did not control for natural history and the passage of time, we cannot estimate what proportion of the observed benefits would have occurred separately from the intervention themselves. Without a control group of equal attention, it could be argued that the benefits observed were related to the degree of attention participants received at our centers. Because one of our goals was to assist in the development of our practice-based research network and to demonstrate that we could recruit, follow, and retain participants, as well as collect and process laboratory specimens, we opted not to include randomization or comparison to a control group in our design.
In the spirit of the individualized care that characterizes the integrative medicine approach to the unique individual, we did not mandate a standardized intervention for all SIMTAP participants. Although this makes it more difficult to define the precise treatment that patients received, the network felt that the personalized treatment plan was preferred. Practitioners of traditional Chinese medicine generally devise individualized treatment plans based on each patient’s unique diagnosis rather than follow a standard intervention based on the complaint. In a seminal randomized controlled trial of Chinese herbal medicine for treatment of irritable bowel syndrome, investigators compared a standard and an individualized Chinese herbal formulation to a placebo
. Results showed that compared with patients in the placebo group, patients in the two active treatment groups had improvements in bowel symptoms as rated by both the patients and their gastroenterologists at the end of the 16-week intervention. However, at follow-up 14 weeks after completion of the treatment, only the individualized herbal medicine treatment group maintained improvement.
The results of SIMTAP suggest that the tailored, multi-modal approach to treating chronic pain combining conventional and complementary therapies improves quality of life and reduces pain, stress and depressive symptoms. The components of integrative medicine that contribute to improving patients’ physical and emotional health require further research since this study is not powered to compare the effectiveness of different combinations to each other. In addition, a comparison of integrative medicine to usual care would help define the effectiveness of different treatment approaches to chronic pain.
Investigating the therapeutic impact of a “whole systems” approach such as our integrative intervention is a daunting challenge, as funding agencies are accustomed to a more reductionist approach to assessing which individual component of a multimodality intervention is the active one. In addition, the conventional approach would be to deliver a standardized intervention to all study participants. These conventions run counter to the philosophy of integrative medicine, which places the needs of the unique person seeking care first and designs an appropriate personalized intervention based on the individual’s assessment, much akin to practitioners of traditional Eastern medicine. New initiatives, such as the Patient Reported Outcome Measurement Information System and the Patient-Centered Outcomes Research Institute, will hopefully have an impact in advancing research of integrative medicine interventions
The 2010 Patient Protection and Affordable Care Act required the Department of Health and Human Services to enlist the Institute of Medicine in examining pain as a public health problem. The recommendations from the institute suggest that among the “steps to improving care, healthcare providers should increasingly aim at tailoring pain care to each person’s experience, and self-management of pain should be promoted”
. Although it is often easier and faster to respond to the patient presenting with chronic pain by writing a prescription, increasingly for a substance with addictive potential, an integrative medicine approach may more closely approximate the Institute of Medicine’s blueprint for transforming health care.