The Pine Street Foundation’s mission is to help people with cancer reach more informed decisions. To this end, we conduct meta-analyses and clinical trials on a variety of topics.
The Pine Street Foundation conducts meta-analyses in collaboration with researchers from around the world. Meta-analysis is a method of systematically selecting relevant primary research, appraising its quality, and synthesizing the results to arrive at a summary conclusion. In our meta-analysis program, we systematically review past clinical trials to evaluate and substantiate the effectiveness of integrative treatment protocols for a wide range of illnesses. Most recently, our reviews have focused on integrative treatments for some of the most common forms of cancer where conventional treatments have had more limited success.
The Pine Street Foundation designs and conducts innovative clinical trials in collaboration with researchers from around the world. The Foundation has an Institutional Review Board (IRB), an internal ethics board that provides oversight for human research subjects’ concerns for other complementary and alternative medicine researchers. Our IRB is registered with the Office for Human Research Protections, which is part of the National Institutes of Health (NIH). Our IRB number is 3082. Our Federal Wide Assurance (FWA) number is 8970. For optimal ethical review, all of the Pine Street Foundation’s own research projects are independently reviewed by an external and independent Institutional Review Board.
RESEARCH IN PROGRESS
EARLY DETECTION OF EPITHELIAL OVARIAN CANCER USING EXHALED BREATH MARKERS:
GC/FT-ICR Mass Spectrometry and Canine Olfaction
Is there meaningful information contained within a person’s breath? Could this information lead to early detection of ovarian cancer? In partnership with Touradj Solouki, Associate Professor of Chemistry at the University of Maine, the Pine Street Foundation seeks to answer these questions by using two of the most sensitive and sophisticated scent detection devices on the planet, a type of mass spectrometer and a dog’s nose. Click here for more on this research.
DOES COMBINING CHINESE HERBAL MEDICINE WITH CHEMOTHERAPY IMPROVE QUALITY OF LIFE, REDUCE TREATMENT SIDE EFFECTS, AND LENGTHEN SURVIVAL IN PATIENTS WITH COLON CANCER?
Many clinical questions encountered by practitioners of Chinese medicine, and by patients receiving treatment, have not yet been formally evaluated for effectiveness in modern research. An important example is whether patients with colon cancer will live longer, and have better quality of life, if they add Chinese herbal medicine to their chemotherapy treatment.
Colorectal cancer is the third most common cancer in men and women, and the second leading cause of cancer death in the United States. Nearly 150,000 new cases are diagnosed every year.(American Cancer Society 2008) Approximately 90% of people diagnosed with localized disease will survive five years, however that drops to 68% if lymph nodes are involved, and 10% when the cancer has spread.(Ellenhorn, Cullinane et al. 2007) Standard chemotherapy for decades has been the drug 5-FU. There was little improvement in survival during the 1980s and 1990s.(Rabeneck, El-Serag et al. 2003) Addition of the drug oxaliplatin improved patient survival by only about 20% (Sanoff, Carpenter et al. 2012), a modest gain for a substantial increase in side effects. Side effects of these drugs can be severe and long lasting, and treatment success is still less than ideal. Randomized trials have suggested that adding Chinese herbal medicine to chemotherapy can lengthen survival in patients with stage IV colon cancer, compared to chemotherapy alone.(Meng, Xu et al. 2003) Chinese herbs also reduce nausea.(Mok, Yeo et al. 2007)
Some studies have shown promise in early research, for example Tian Xian Liquid (Radix Ginseng, Cordyceps, Radix Astragali, Radix Glycyrrhizae, Rhizoma Dioscorea, Margarita, Fructus Lycii, Ganoderma, Fructus Ligustri Lucidi, Herba Scutellariae Barbatae) can help prevent the spread of cancer cells (Chu, Sze et al. 2011). That formula also enhances the function of important genes that control cancer cell growth (Sze, Wong et al. 2011). However, news reports have appeared suggested bias or fabrication of research results. Utilizing systematic search skills and contact with professional colleagues, we also intend to seek this out where possible, to assess the impact of that bias on reported study outcomes. A meta-analysis on this topic was published recently (Zhong, Chen et al. 2012), but includes only approximately half the randomized trials we have identified in preliminary database searches for this project.
We will follow a systematic, focused approach to conducting this research, using methods I helped develop.(Pai, McCulloch et al. 2004) This meta-analysis will start with a systematic review, in which we will search medical databases around the world, to identify every known published article on the use of Chinese herbal medicine in colon cancer treatment. Beginning a meta-analysis with this crucial systematic review process helps avoid biased conclusions that may result if papers are “cherry-picked”, and others are left out of the analysis. Each individual study included in a meta-analysis plays the same role as an individual patient in a clinical trial; therefore, thorough searching and identification of all available published trials is essential in achieving a balanced analysis.
We will then extract relevant data from each study, looking for the contribution of Chinese herbal medicines on immediate results (do herbal medicines reduce drug toxicity such as nausea or damage to white blood cells?), and long-term results (do people using herbal medicine have better quality of life and live longer after treatment?), as compared to treatment with chemotherapy alone. We will also examine the quality of the published studies, to understand what study quality problems are most significant and where improvement is needed. The Jadad scale for evaluating study quality will be used for this step.(Jadad, Moore et al. 1996) This scale is used to evaluate the quality of randomized trials, including specific items such as whether appropriate randomization and blinding methods were used.
The clinical outcomes data obtained from studies will be combined into a larger analysis, allowing an understanding how Chinese herbal medicines perform in larger groups of people than typically possible in one clinical trial. We will analyze all trials together, and then subgroups of trials in which the same herbal combinations were used, following the approach used in our previously published lung cancer meta-analysis.(McCulloch, See et al. 2006) In preparing the manuscript for peer-reviewed publication, we will use the recognized standard for reporting of meta-analyses of randomized trials, called QUOROM.(Moher, Cook et al. 1999) This standard defines quality criteria for how researchers should report methods and results in published meta-analyses: which databases were searched, how studies were selected, how the quality of studies was assessed, how patient and outcomes data were extracted, and how the outcomes data were analyzed. It also ensures adequate reporting of study characteristics.