Acupuncture improves certain aspects of sleep in hematopoietic stem cell transplantation patients: a secondary analysis of a randomized controlled trial.

BACKGROUND: High-dose chemotherapy followed by hematopoietic stem cell transplantation (HSCT) is associated with a high symptom burden including sleep disturbance. Here we present the results of a secondary analysis of a randomized, sham-controlled trial assessing the effect of acupuncture on sleep quality during HSCT. METHODS: Adult multiple myeloma patients undergoing inpatient and outpatient autologous HSCT were randomized and blinded to receive either true or sham acupuncture (by licensed acupuncturists) once daily for 5 days starting the day after chemotherapy. Sleep onset, total sleep time, sleep efficiency percentage and sleep-onset latency time were assessed using an actigraphy-based sleep monitor. A multivariate regression analysis was conducted to compare the average area-under-the-curve of five acupuncture intervention days for each sleep outcome between groups, adjusted by baseline score and inpatient or outpatient chemotherapy stratum. RESULTS: Over 32 months, 63 patients were enrolled. Participants undergoing true acupuncture experienced a significant improvement in sleep efficiency when compared to sham (-6.70, 95% CI -13.15, -0.25, p = 0.042). Subgroup analysis showed that the improvement was more prominent in the inpatient setting (-9.62, 95% CI -18.76, -0.47; p = 0.040). True acupuncture tended to improve wake time after sleep onset (WASO; -10.95, p = 0.054). Between-group differences in other sleep related variables were not statistically significant. CONCLUSION: Our data suggest that true acupuncture may improve certain aspects of sleep, including sleep efficiency and possibly WASO, in multiple myeloma patients undergoing HSCT. By studying patient reported outcomes in future larger scale studies, acupuncture's role in improving sleep quality during HSCT treatment could be further elucidated. TRIAL REGISTRATION NUMBER: NCT01811862 (ClinicalTrials.gov).

Characterization of chemotherapy-induced peripheral neuropathy using patient-reported outcomes and quantitative sensory testing.

PURPOSE: Chemotherapy-induced peripheral neuropathy (CIPN) is a common, debilitating side effect in cancer survivors. This study aimed to assess the characteristics of quantitative sensory testing (QST) and its correlation with patient-reported outcomes (PROs) in cancer patients with and without CIPN. METHODS: We conducted a cross-sectional analysis using baseline data from two clinical trials in solid tumor cancer survivors with no CIPN symptoms rated < 2 on a 0-10 Numerical Rating Scale (NRS) or moderate-to-severe CIPN rated ≥ 4 on the NRS. We collected PROs (NRS, Neuropathic Pain Scale, and Functional Assessment of Cancer Therapy-Gynecologic Oncology Group/Neurotoxicity subscale at baseline. QST [Tactile Threshold (TT), Vibration Threshold (VT), Thermal Threshold (THT)] measurements were used to assess sensory fiber function; they were compared between patients with and without CIPN using Wilcoxon rank-sum tests. We used Spearman correlation coefficients to estimate associations between PROs and QST in all patients. RESULTS: Among 116 participants with CIPN (median NRS 5.00) and 10 participants without CIPN (median NRS 0.00), the median (interquartile range) TT was 3.84 (3.47, 4.12) and 3.53 (3.00, 3.84) in feet, respectively (p = 0.043). The median VT was 17.90 (9.42, 26.95) and 7.73 (5.94, 11.11) in feet, respectively (p = 0.001). Thermal cool threshold was 30.00 °C (28.90, 30.57) and 30.67 °C (30.57, 30.93), respectively (p = 0.007). Correlation coefficients between PROs and QST measures ranged between 0.02 and 0.50 in absolute magnitude. CONCLUSION: Patients with moderate-to-severe CIPN had significantly impaired tactile, vibratory, and thermal thresholds compared to patients without CIPN. QST correlates with PROs, suggesting CIPN symptom severity may correspond to sensory fiber functionality. QST may be incorporated into future CIPN research.

Symptom burden and willingness to participate: implications for herbal clinical trials in lung cancer.

BACKGROUND: People with lung cancer are interested in using herbs for symptom management. However, well-designed clinical trials are lacking. We aimed to quantify symptom burden and willingness to participate in herbal clinical trials among this population. METHODS: We conducted a cross-sectional analysis using data collected from people with lung cancer at an oncology clinic at an academic cancer center. The primary outcome was self-reported willingness to participate in herbal research. We measured symptoms using the MD Anderson Symptom Inventory (MDASI). Multivariate logistic regression was performed to explore the relationship between demographic/ clinical factors, symptom burden, and willingness to participate in herbal studies. RESULTS: Among 288 participants, 55% were female, 42% were >65 years, 54% had stage IV cancer, and 86% had non-small cell lung cancer (NSCLC). Nearly half (46%) indicated willingness to participate in an herbal clinical trial. The most commonly reported moderate to severe symptoms (≥4 on the MDASI scale) were fatigue (57%), drowsiness (44%), disturbed sleep (43%), distress (42%), and dyspnea (36%). In multivariate analyses, higher education was significantly associated with willingness to participate in herbal studies (adjusted odds ratio 1.87, 95% confidence interval, 1.12-3.10, P=0.016), while symptom burden was not. CONCLUSIONS: People with lung cancer experience high rates of symptom burden. Nearly half of our participants expressed willingness to participate in an herbal clinical trial, particularly those with higher education. These findings can inform the design of future herbal clinical trials targeting common symptoms in lung cancer populations.

Preliminary Efficacy and Safety of Reishi & Privet Formula on Quality of Life Among Non-Small Cell Lung Cancer Patients Undergoing Chemotherapy: A Randomized Placebo-Controlled Trial.

BACKGROUND: Cancer patients often experience decreased quality of life during chemotherapy. This study aimed to determine the preliminary efficacy and safety of Reishi & Privet Formula (RPF) for maintaining quality of life among patients with non-small cell lung cancer (NSCLC) undergoing chemotherapy. METHODS: We conducted a phase II randomized, double-blind, placebo-controlled clinical trial in China. Adults with NSCLC scheduled to receive chemotherapy were randomly assigned (3:1 ratio) to receive oral RPF (3.36 g/day) or placebo daily for 6 weeks. The main outcome was the Functional Assessment of Cancer Therapy-Lung (FACT-L). We evaluated RPF's safety profile using the Common Terminology Criteria for Adverse Events and assessed changes in outcome measures from baseline to weeks 3 and 6 using a linear mixed effects model. RESULTS: We enrolled 82 participants across 8 cancer centers in China. The median age was 59 years, 56 (68%) had advanced cancer. Compared with the placebo group, the RPF group had nonstatistically significant higher quality of life as measured by the FACT-L total score (P = .086) over 2 cycles of chemotherapy. The RPF group was associated with a nonsignificant better general health (P = .050) and emotional well-being (P = .090) than the placebo group. Adverse events rates did not differ between groups. CONCLUSIONS: This study demonstrated preliminary safety and suggests a promising trend in RPF's effect on maintaining quality of life and emotional well-being among NSCLC patients undergoing chemotherapy. Future adequately powered randomized-controlled trials are needed to verify the efficacy and safety of RPF in cancer patients undergoing chemotherapy.

Acupuncture for Bortezomib-Induced Peripheral Neuropathy: Not Just for Pain.

BACKGROUND: Bortezomib-induced peripheral neuropathy (BIPN) is a common and debilitating side effect. Our pilot study demonstrated that acupuncture is safe and can decrease total neuropathic symptoms. However, there is lack of knowledge in which individual BIPN symptoms benefited from acupuncture. PURPOSE: To characterize individual symptoms reduced by acupuncture in patients with BIPN. METHODS: Patients with multiple myeloma treated with bortezomib who developed BIPN grade 2 or above, based on National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), were enrolled and received 10 acupuncture treatments over 10 weeks. Self-reported BIPN-associated symptoms assessments were collected weekly at baseline, during, and after acupuncture treatment using the Neuropathy Pain Scale (NPS) and the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (FACT/GOG-Ntx) questionnaires. Changes in individual symptoms were analyzed based on FACT/GOG-Ntx and NPS scores. RESULTS: There were statistically significant reductions in individual symptoms in both NPS and FACT/GOG-Ntx. The FACT/GOG-Ntx reductions were most pronounced in hand/feet numbness/tingling, discomfort, and trouble walking. The sensory symptoms, such as tingling and numbness, especially in the feet, reduced the most ( P < .0001), and motor dysfunction also reduced significantly ( P = .0001). Both hearing and dysfunction scores were also statistically significantly increased, indicating improved symptoms. The NPS scores showed significant symptom relief in all 10 items from the NPS assessment, particularly in cold sensitivity and an unpleasant feeling. CONCLUSIONS: Acupuncture can improve multiple symptoms associated with BIPN, particularly numbness and tingling in hands and feet, cold sensitivity, and an unpleasant feeling. Further randomized control trials are warranted to confirm our findings.

Short-term venlafaxine v. lithium monotherapy for bipolar type II major depressive episodes: effectiveness and mood conversion rate.

BACKGROUND: Controversy exists over antidepressant use in bipolar II depression. AIMS: To compare the safety and effectiveness of antidepressantv.mood stabiliser monotherapy for bipolar type II major depressive episodes. METHOD: Randomised, double-blind, parallel-group, 12-week comparison of venlafaxine (n= 65)v.lithium (n= 64) monotherapy in adult out-patients (trial registration numberNCT00602537). RESULTS: Primary outcome - venlafaxine produced a greater response rate (67.7%)v lithium (34.4%,P<0.001). Secondary outcomes - venlafaxine produced a greater remission rate (58.5%v 28.1%,P<0.001); greater decline in depression symptom scores over time (ß = -5.32, s.e. = 1.16, χ(2)= 21.19,P<0.001); greater reduction in global severity scores over time (ß = -1.05, s.e. = 0.22, w(2)= 22.33,P<0.001); and greater improvement in global change scores (ß = -1.31, s.e. = 0.32, χ(2)= 16.95,P<0.001) relative to lithium. No statistically significant or clinically meaningful differences in hypomanic symptoms were observed between treatments. CONCLUSIONS: These findings suggest that short-term venlafaxine monotherapy may provide effective antidepressant treatment for bipolar II depression without a statistically significant increase in hypomanic symptoms relative to lithium.

Safety and effectiveness of continuation antidepressant versus mood stabilizer monotherapy for relapse-prevention of bipolar II depression: A randomized, double-blind, parallel-group, prospective study.

OBJECTIVE: Compare the safety and effectiveness of continuation antidepressant versus mood stabilizer monotherapy for preventing depressive relapse in bipolar II disorder. METHODS: Subjects ≥18 years old with bipolar II depression (n=129) were randomized to double-blind venlafaxine or lithium monotherapy for 12 weeks. Responders with a ≥50% reduction in depression score were continued for an additional 6 months of relapse-prevention monotherapy. Primary outcome was depressive relapse during continuation monotherapy. Secondary outcomes included sustained response rate from initiation of treatment to study end-point, relapse hazard, time to relapse, change in mania ratings, and frequency of treatment-emergent sub-syndromal hypomania and/or depressive episodes. RESULTS: Venlafaxine produced greater sustained response rate versus lithium (p<0.0001); however, there was no difference in relapse rate for venlafaxine (7.5%) versus lithium (26.7%) (p=0.079); relapse hazard (p=0.073), or time to relapse (p=0.090) between treatment conditions during continuation monotherapy. There were no group differences in mania rating scores over time and no difference in frequency or duration of syndromal or sub-syndromal hypomanic episodes. There were more sub-syndromal depressive episodes during lithium monotherapy (p=0.03). LIMITATIONS: Sample size was limited by the lower sustained response rate for lithium versus venlafaxine; study was not specifically powered to detect differences in treatment-emergent hypomanic or depressive episodes between groups. CONCLUSION: Results suggest that continuation venlafaxine monotherapy may provide similar prophylactic effectiveness relative to lithium, with no difference in treatment-emergent hypomanic episodes and without the need for frequent serum lithium level and metabolic monitoring. Larger, prospective trials are needed to confirm these observations.