Research Portfolio
A SYMPTOM MANAGEMENT EFFICACY STUDY TO REDUCE DISTAL NEUROPATHIC PAIN IN HIV (NIH-R01-NR017917)
Principal Investigator: Joyce K. Anastasi
DESCRIPTION (NIH RePORT): Distal sensory peripheral neuropathy (DSP) is a chronic, debilitating painful condition affecting quality of life in 20%-50% of persons living with HIV. Treatments prescribed to manage DSP pain, such as nonnarcotic and narcotic analgesics, antidepressants and anticonvulsants, are largely ineffective. Our studies, using acupuncture and moxibustion (Acu/Moxa) to manage HIV DSP pain, show promise as an effective therapy. This study builds on preliminary data to test a novel approach, Acu/Moxa, to manage chronic lower-limb DSP pain in adults living with HIV. IMPACT: there are no FDA-approved agents for this indication in HIV. Effective management of DSP pain is an unmet therapeutic need for this population. Results from this study can provide patients and clinicians with an evidenced-based non-pharmacologic therapeutic option to manage this painful condition. The literature, our clinical experience, our preliminary studies and strength of our team provide a strong rationale to conduct a rigorous, randomized, blinded, placebo-controlled clinical trial of the efficacy of Acu/Moxa for HIV DSP pain that adheres to the CONSORT and STRICTA guidelines.
Subjects with HIV-related lower limb DSP pain are randomized to one of four Conditions: 1) Standard (fixed) protocol Acu/Moxa, 2) Individualized (tailored) protocol Acu/Moxa, 3) Sham Acu/Placebo Moxa (control), or 4) WaitList (control). Subjects attend six weeks of twice weekly treatment sessions and 3 non-treatment follow-up sessions at weeks 9, 11, and 15. All subjects are assessed by a blinded diagnostic acupuncturist (DA) and those assigned to Conditions 1, 2 and 3 receive treatments by an unblinded treating acupuncturist (TA). Specific Aims are: #1 determine group differences in weekly average pain (Gracely Pain Scale) at the end of treatment (Tx) and end of follow-up (F/U); SA#2 determine group differences in improvement in specific sensory symptoms (Subjective Peripheral Neuropathy Screen and neurological sensory testing (NST)) and patient-rated effectiveness (Clinical Global Improvement, NIH PROMIS Pain Intensity and Health-Related Quality of Life (MOS-HIV)) at Tx and F/U; SA#3 determine group differences in safety profiles; and SA#4, explore how baseline measures, TCM diagnoses, NST and pain medication use predict response to treatment. The primary intent-to-treat analysis of group differences in within-subject longitudinal change from baseline to Tx and F/U uses linear mixed models for repeated measures (LMMrm) with fixed effects for DA, treatment group, time, their interactions with covariate adjustment for the level of the outcome at baseline (SA#1 & SA#2). Preliminary studies estimate of “medium” effect sizes for the Gracely Pain Scale and 20% attrition indicates the need for 196 subjects to achieve 80% power and 5% alpha to detect the superiority of one active treatment to control, and one active treatment to the other. Cross-sectional and longitudinal associations between TCM diagnoses, NST assessments and pain medication use with change in patient-rated effectiveness will use multiple correlation/regression for aim #4.
PROTOCOL- VS PATIENT-ORIENTED TCM PRACTICES: A RCT FOR IBS SYMPTOM MANAGEMENT (NIH-R01-NR010730)
Prinicpal Investigator: Joyce K. Anastasi
DESCRIPTION (NIH RePORT): This study will test the efficacy of Acupuncture/Moxibustion (Acu/Moxa) to improve the symptoms associated with Irritable Bowel Syndrome (IBS). IBS has been defined as abdominal pain/discomfort in the mid or lower gastrointestinal (Gl) tract, associated with defecation or a change in bowel patterns with features of disordered defecation. IBS affects 15 percent to 20 percent of North Americans. Current therapies: dietary modification, psychotherapy and drug therapies, are still under investigation, none are curative and some have significant side effects. The traditional Chinese medicine (TCM) approach of acu/moxa developed over centuries in Asia offers a subtle, holistic approach to symptom management for IBS. Acupuncture (including moxibustion) has been widely used for the treatment of various Gl disorders. However, few IBS acupuncture studies have the necessary rigor to evaluate this treatment. The proposed study is a randomized, blinded, sham/placebo controlled clinical trial of Acu/Moxa to reduce abdominal pain/discomfort and IBS secondary supporting symptoms (IBS-SecS) (intestinal gas, bloating, stool consistency). 171 adults, diagnosed with IBS-diarrhea (IBS-D) according to ROME Ill criteria, will be randomized to one of three conditions: 1: Protocol-oriented Acu/Moxa (standard); 2: Patient-oriented Acu/Moxa (based on individualized TCM diagnosis and point prescription) and 3: Sham acupuncture/ Placebo moxibustion (control group). All subjects will attend a screening/intake session followed by two treatment sessions per week for 4 weeks, one treatment session per week for 4 weeks, and 2 long-term non-treatment follow-up sessions at weeks 12 and 24. All subjects will be assessed by a Diagnostic Acupuncturist (blinded to treatment assignments), receive interventions appropriate to their condition assignments (by licensed acupuncturists trained in TCM), and complete the same instruments and daily symptom diaries for the duration of the study.
ACUPUNCTURE FOR CHRONIC NAUSEA IN PTS WITH HIV: A RCT (NIH-R01-NR009364)
Principal Investigator: Joyce K. Anastasi
DESCRIPTION (NIH RePORT): This proposal will test the use of a Traditional Chinese Medicine (TCM) approach, acupuncture, to reduce the severity of chronic nausea among HIV positive individuals. Nausea is a common symptom with HIV disease. Although Ols associated with HIV/AIDS have decreased due to new drug cocktails, many of these drugs have nausea as a side effect. Anti-emetics prescribed for nausea are commonly ineffective in this group. Acupuncture shows promise in serving as an adjunctive therapy with conventional medical interventions to manage chronic nausea. In Asian countries, acupuncture has been widely used to treat various gastrointestinal (Gl) disorders. To date, there is only 1 published report using acupuncture for the management of Gl symptoms inclusive of nausea in persons with HIV/AIDS, however this study lacked rigor. Despite the paucity of well-designed studies on acupuncture for nausea in HIV, there is substantial information regarding the physiological effects of acupuncture on the gastrointestinal system. The information obtained from the literature, the clinical experiences of the research team and our preliminary studies provide a strong foundation to conduct a rigorous controlled, clinical trial of acupuncture for the management of chronic nausea in persons with HIV/AIDS. The proposed study is a randomized, blinded (subject and evaluator), sham acupuncture controlled clinical trial. The subjects in the proposed experiment will be 159 men and women with HIV infection who have a history of chronic nausea for 3 months or greater and show evidence of 2 or more episodes of nausea and/or report a duration of 2 hours or greater (per day) in 2-week prospective baseline symptom diaries. Subjects will be randomized to 1 of 3 conditions: Condition 1, subjects receive Standard acupuncture; Condition 2, subjects receive Individualized acupuncture based on TCM Diagnosis and point prescription; Condition 3, (Control Group), subjects receive Sham acupuncture. All subjects will attend 16 scheduled sessions over 24 weeks; assessed by a diagnostic acupuncturist (blinded to treatment assignments); submit symptom diaries. There will be 4 weeks of twice weekly treatment sessions, 4 weekly treatment sessions and 3 follow-up sessions at weeks 12, 16 and 24. All conditions will be identical in duration and be administered by licensed acupuncturists trained in TCM.
Distal Sensory Peripheral Neuropathy in HIV - NIH-R21-AT003092
Prinicpal Investigator: Joyce K. Anastasi
DESCRIPTION (NIH RePORT)): This proposal will test the use of a Traditional Chinese Medicine (TCM) approach, acupuncture/moxibustion (Acu/Moxa), to reduce the severity of pain associated with distal symmetric peripheral neuropathy (DSP) among persons with HIV/AIDS. DSP is the most frequent neurologic complication of HIV infection. The etiologies recognized to cause DSP include neurotoxic side effects of medications, advanced immunosuppression, and nutritional deficiency. Treatments prescribed to manage the pain associated with DSP, such as nonnarcotic and narcotic analgesics, antidepressants and anticonvulsants, are largely ineffective. Therefore, non-invasive Acu/Moxa treatment may serve as a valuable adjunctive therapy with conventional medical interventions to manage DSP. To date, there have been five published studies using acupuncture for peripheral neuropathy in persons with HIV/AIDS. However, they exhibited several flaws, and lacked the scientific rigor to adequately evaluate the treatment. Despite the paucity of well-designed randomized, controlled, blinded studies on acupuncture for DSP in HIV, there is substantial information regarding the physiological effects of acupuncture on the neurological system. Furthermore, no studies examined the use of acupuncture with moxibustion (artemisia vulgaris) for DSP. In TCM, acupuncture and moxibustion complement each other to form one mode of therapy. This proposal will establish the feasibility and provide foundation for designing a larger clinical trial. The proposed feasibility study is a sample-size-limited, randomized, blinded (subject and evaluator), sham acupuncture/placebo moxibustion (Sham Acu/Placebo Moxa) controlled clinical trial. The subjects in this pilot study will be 50 men and women with HIV infection who have a diagnosis of DSP. Subjects will be randomized to one of two experimental intervention conditions: Condition 1, subjects receive Acu/Moxa Treatment, and Condition 2, (Control Group), subjects receive Sham Acu/Placebo Moxa. All subjects in Conditions 1 & 2 will attend 16 scheduled sessions over 15 weeks, be administered the same instruments, and submit their daily symptom diaries for analysis. There will be six weeks of twice weekly treatment sessions, and three follow-up sessions at weeks 9, 11 and 15. All conditions will be identical in duration and be administered by licensed acupuncturists trained in TCM. Data from daily symptom diaries and questionnaires will be analyzed with mixed model analysis of variance for between-group difference in the temporal pattern of symptom reduction at baseline, after 6 weeks of twice weekly treatment, and after 2, 4, and 8 weeks of no-treatment follow-ups. In addition, exploratory analyses will assess the logistics of a CAM clinical trial for HIV/AIDS related DSP in preparation of a larger clinical trial. In response to RFA-AT-05-004, the investigators will evaluate the role of Acu/Moxa in reducing the symptoms of DSP related to HIV/AIDS and treatment side effects. The effects of symptom reduction on quality of life will also be examined. In addition, this application originates from an institution with a NIH Center for AIDS Research (CFAR) and a supportive community network.
SYMPTOM MANAGEMENT FOR IRRITABLE BOWEL SYNDROME CONSTIPATION (IBS-C) NIH-R01-NR013695
Prinicpal Investigator: Joyce K. Anastasi
DESCRIPTION (NIH RePORT): Irritable Bowel Syndrome (IBS) is a chronic condition which affects 15% to 20% of North Americans. IBS is defined as abdominal pain/discomfort in the mid or lower gastrointestinal (GI) tract, associated with defecation or a change in bowel patterns with features of disordered defecation. The chronic symptoms of IBS have been linked with decreased quality of life, decreased work productivity and increased healthcare utilization. Current therapies include dietary modification, psychotherapy, probiotics, and pharmaceutical agents. None of these therapies are curative, some have life threatening side effects and results from research have been equivocal. Acupuncture/Moxibustion (Acu/Moxa), used in traditional Chinese medicine (TCM), is used to manage various GI disorders. However, few acupuncture studies have had the necessary rigor to evaluate this therapy. This application follows accepted standards of rigorous clinical trials with the primary aim to investigate the efficacy of Acu/Moxa in a randomized, blinded, sham/placebo controlled study to reduce abdominal pain/discomfort and IBS secondary supporting symptoms (IBS-SecS) (intestinal gas, bloating, stool consistency). 183 adults, diagnosed with IBS-Constipation (IBS-C) based on the ROME III criteria, will be randomized to one of three conditions: 1) Protocol-oriented Acu/Moxa (Standard); 2) Patient-oriented Acu/Moxa (Individualized TCM diagnosis and point prescription), or 3) Sham Acu/Placebo Moxa (Control). All subjects will attend a screening/intake session, twice weekly treatment sessions for 4 weeks, one weekly treatment sessions for 4 weeks, and 2 long-term non-treatment follow-up sessions at weeks 12 and 24. A Diagnostic Acupuncturist (blinded to treatment assignment) assesses each subject and prescribes Acu-points; a licensed Treating Acupuncturist trained in TCM delivers the intervention according to the randomization assignment; and all subjects complete the same instruments and daily symptom diaries for the duration of the study.
HIV, LIPIDS AND DIETARY STRATEGIES NIH-R03-NR009476
Principal Investigator: Bernadette Capili
DESCRIPTION (NIH RePORTER): The purpose of this study is to test the feasibility of conducting a controlled dietary study, supplemented with 4 grams of omega-3 fatty acids (fish oil) per day to reduce serum triglyceride levels in HIV/AIDS patients taking highly active antiretroviral therapies (HAART) with Protease Inhibitors. In recent years/cardiovascular disease (CVD) risk factors have been recognized among individuals living with HIV/AIDS. CVD risk factors in HIV have been associated with the medications used to manage HIV. Strong associations between a specific class of HIV medication, protease inhibitors (PI), has been implicated in elevating serum levels of triglycerides in people using these agents. Effective treatments are needed to prevent the sequelae of CVD from further complicating the disease process, management and quality of life. Current treatments for hypertriglyceridemia in HIV, are not always effective and can be dose limited due to interactions with HAART regimens. 32 men and women diagnosed with HIV/AIDS taking PI-HAART with elevated levels of fasting serum triglyceride will be randomized to 1 of 2 conditions in a prospective, placebo-controlled, parallel group, feasibility clinical trial. The 2 conditions are: Condition 1, subjects will receive prepared meals using usual foods based on the National Cholesterol Education Program (NCEP) Therapeutic Lifestyle Changes (TLC) dietary guidelines supplemented with 4 grams offish oil per day; and Condition 2 (control group), subjects will receive prepared meals using usual foods based on the NCEP TLC dietary guidelines with placebo. All subjects will attend one intake/screening, one baseline and 16 sessions over 10 weeks. All subjects will also be administered the same instruments, undergo the same evaluations and laboratory testing for the duration of the study. Subjects will be encouraged to maintain usual level of physical activity for the duration of the study.
SYMPTOM MANAGEMENT--NAUSEA & VOMITING IN HIV PATIENTS NIH-F31-NR007317
Principal Investigator: Bernadette Capili
DESCRIPTION: (NIH RePORTER) The focus and objective of this level one application is to further refine and explore the symptoms of nausea and vomiting in patients with the human immunodeficiency virus (HIV). Forty-two percent of medications used for treating HIV and associated manifestations, have nausea and vomiting listed as adverse side effects. However, the symptoms and the management of nausea and vomiting have not been well studied in HIV research. Issues in quality of life, such as, physical functioning, psychological health and social/role functioning needs to be further assessed in relation to nausea and vomiting. It is critical to address and answer these issues, in order to gain a better understanding of how nausea and vomiting affects an individual's life, in addition to being infected with HIV. With further exploration and knowledge, the applicant's ultimate goals are to develop, test and analyze clinical strategies using randomized clinical trials to reduce the symptoms of nausea and vomiting in patients with HIV. It is the applicant's objective to develop clinical strategies that are not only therapeutic and beneficial, but also acceptable and tolerable for those affected.
Heart Healthy Living in HIV: A Preliminary Study P30-NIH-NR010677 - (Pilot)
Principal Investigator: Bernadette Capili
In recent years, cardiovascular disease (CVD) risk factors such as hyperlipidemia, impaired glucose tolerance (IGT) and insulin resistance (IR) have become prevalent among individuals with HIV. The CVD risk factors in HIV have been associated with the medications used to manage HIV. In addition, overweight and obesity are rising among individuals living with HIV. With the increased incidence of hyperlipidemia, glucose abnormalities, overweight and obesity, new importance must be placed on lifestyle modifications, such as diet and physical activity. In the general population, self-management programs have been integral to the successful management of chronic illnesses such as diabetes mellitus and hyperlipidemia through life-style changes. Since the success of self-management programs require knowledge and strong motivation in making life-style changes,the purpose of this exploratory study is to understand the perception and knowledge in people living with HIV regarding CVD risk, prevention, healthy eating, exercising, and current behaviors related to health, as well as barriers to lifestyle change. Specific aims are:. 1) To understand the perception of CVD risk and prevention, 2) To explore experiences and beliefs about diet and exercise, 3) To investigate motivations and barriers in making life-style changes related to the prevention of CVD, and 4) To evaluate the relationship between body mass index (BMI) level and gender on nutrition knowledge, estimated nutritional intake (via 3-day food diary), physical activity, anthropometric measurements, lipid profile, and glucose level. The primary method for this study is focus groups; questions will be guided by the Health Belief Model and the Social Cognitive Theory. Focus groups will be segmented by gender and BMI levels:1) normal weight men, 2) normal weight women, 3) overweight men, 4) overweight women, 5) obese men, and 6) obese women resulting in a total of 12 to 24 focus groups. As a complement to the PI’s analysis, an independent investigator with expertise in biobehavioral cardiogy will independently interpret the focus group data. The data from the focus groups will be triangulated with completed study questionnaires such as demographic, medical history, nutrition knowledge, 3-day food diary, physical activity, anthropometric measurements, lipid profile, glucose level, and BMI to explore biobehavioral relationships. The information generated from this study will assist the investigative team in developing a self-management intervention that will be considered feasible and sensitive to the needs of people with HIV to reduce the modifiable risks associated with CVD.
Body mass index and nutritional intake in patients with HIV and chronic diarrhea P20-NIH-NR07799 (Pilot)
Principal Investigator: Bernadette Capili
Abstract Purpose: The purpose of this study was to examine the differences in nutritional intake and body mass index (BMI) in HIV patients with chronic diarrhea via secondary analysis of patients’ nutritional diaries. A secondary purpose was to evaluate the quality of diets against national dietary guidelines. Data sources: Seventy-five ambulatory patients with HIV were included in this study. Patients were categorized using baseline BMI as normal weight (BMI 18.5–24.9 kg/m2), overweight (BMI 25.0-29.9 kg/m2), and obese (BMI 2:30.0 kg/m2). Seven-day nutritional diaries were used to estimate diet in terms of dietary fats, cholesterol, fiber, protein, and sugar. A one-way analysis of variance was conducted to evaluate the relationship between BMI and mean nutritional intake from fat, saturated fat, polyunsaturated fat, monounsaturated fat, cho- lesterol, fiber, and sugar. Conclusions: 39.7% and 13.3% of participants were overweight and obese, respectively. The mean intake of fat, saturated fat, and cholesterol was higher than the recommended levels by the National Cholesterol Education Program (NCEP), while the mean intake of monounsaturated fat, polyunsaturated fat, and fiber was below the NCEP guideline. Although the results were not statistically different between groups, grams of fiber intake were lowest for individuals with BMI 2:30.0 kg/m2. Implications for practice: Advanced practice nurses should encourage increased physical activity and healthy diets at each visit for individuals living with HIV. The continued use of nutritional supplements to boost weight should also be reviewed at each visit to prevent the consumption of unnecessary calories.