Table 2.
Methodological Assessment of Observational Studies.
Observational studies (n = 3) | |||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|
Study ID | Indication | Participants | Criteria | Intervention | Dropout | Objectives | Duration of treatment (follow-up) | Main results | Funding | ||
Sample size | Baseline comparability | Inclusion | Exclusion | Treatment vs control (n) | Treatment vs control (n) | ||||||
Chokshi et al 40 | Acupuncture for symptom management | Children receiving cancer treatment (n = 90) | Differences in age of participants accepting acupuncture compared to those who did not. The ethnicity of patients/parents was significantly associated with acceptance of acupuncture. | Acupuncture naive children/adolescents undergoing treatment for cancer at Columbia University Medical Center | Children who had previous experience with acupuncture and children with planned treatment protocols less than 6 mo | Individualized acupuncture (n = 49) vs CAM modalities (massage, yoga, meditation, nutrition counseling) (n = 41) | NR | Evaluate the use of acupuncture as a component of existing supportive care regimens among children and adolescents undergoing treatment for cancer | 6 mo | Acupuncture was more likely than other CAM modalities to be used for gastrointestinal/constitutional symptoms (P > .0001), lack of energy (P = .0001), and pain (P = .001) | NR in publication |
Kennedy et al 44 | Antioxidants supplements (vitamin E; carotenoid; betacaroten; vitamin A) for inadequate plasma antioxidant concentrations | Children and adolescents with ALL (n = 103) | NA (1 single group) | Children and adolescents 1 to 21 y old with newly diagnosed ALL | NR | Received vitamin E; carotenoid; betacaroten; vitamin A (n = 100) | Timepoint 1: n = 3; timepoint 2: n = 16, timepoint 3: n = 16 | Investigate whether patients with sufficient antioxidant intakes while undergoing chemotherapy will have better tolerance to the treatment and experience fewer treatment-related adverse effects than those with insufficient antioxidant intakes | 6 mo | Greater vitamin C intake was associated with fewer therapy delays, less toxicity, and fewer days in hospital. Greater vitamin E intake was associated with a lower incidence of infection. Greater betacaroten intake was associated with a decrease in toxicity. Lower intakes of antioxidants were associated with increase in adverse side effects of chemotherapy. | Supported by a grant from the American Institute for Cancer Research, The Lener and Schwartz Family, and the American Cancer Society |
Medina Córdoba and Pérez Villa 45 | Non-pharmacological measures (touch, play, music) for pain | Children with ALL (n = 35) | NA (1 group only) | Children <18 y old diagnosed with ALL | Children without clinical information on variables of interest; parents who show lack of interest | Touch; encourage children; explaining the procedures; music; play; video games; movies; thought replacement; images; drawing; comparing pain; breathing; massage; muscle contraction; relaxation images; TV; hot and cold applications (n = 35) | No dropout | Evaluate non-pharmacological measures to treat pain for children with ALL | As long as the patient was in the hospital, the average stay was 7 d | Music was the one factor that significantly improved pain (P = .01) | NR in publication |
Abbreviations: ALL, acute lymphoblastic leukemia; NR, not reported; NA, not applicable.