scholarly journals Impact of integrative open dialogue about complementary alternative medicine. A phase II randomized controlled trial

2021 ◽  
Author(s):  
Mette Stie ◽  
Charlotte Delmar ◽  
Birgitte Nørgaard ◽  
Lars Henrik Jensen
Keyword(s):  
Overall Survival ◽  
Psychological Distress ◽  
Side Effects ◽  
Alternative Medicine ◽  
Controlled Study ◽  
Complementary Alternative Medicine ◽  
Randomized Controlled ◽  
Antineoplastic Treatment ◽  
Open Dialogue ◽  
Grade 3

Abstract Complementary alternative medicine (CAM) may reduce the symptom burden of side effects to antineoplastic treatment but also cause new side effects and non-adherence to conventional treatment. The aim of this randomized controlled study was to investigate the impact of integrative open dialogue about CAM (IOD-CAM) on cancer patients’ health and quality of life (QoL). Patients undergoing curative or palliative antineoplastic treatment were randomly assigned to standard care (SC) plus IOD-CAM or SC alone. A nurse specialist facilitated IOD-CAM in one or two sessions. The primary endpoint was the frequency of grade 3–4 adverse events (AE) eight weeks after enrollment. Secondary endpoints were frequency of grade 1–4 AE and patient reported QoL, psychological distress, perceived information, attitude towards and use of CAM 12 and 24 weeks after enrollment. Survival was analyzed post-hoc. Fifty-seven patients were randomized to IOD-CAM and 55 to SC. No significant difference in frequency of grade 3–4 AEs was shown between the two groups eight weeks after enrollment. The same applied to grade 1–4 AE and QoL, psychological distress, and perceived information 12 and 24 weeks after enrollment. However, a tendency towards better QoL, improved survival, and lower level of anxiety was found in the IOD-CAM group. IOD-CAM is not superior to SC in reducing frequency of AEs in patients undergoing oncology treatment. IOD-CAM does not compromise patient safety; it may reduce psychological stress, and improve QoL and overall survival. Further research on the effect of IOD-CAM on emotional well-being and overall survival is warranted.

Postoperative analgesia by adding acupuncture to conventional therapy, a non-randomized controlled trial

2018 ◽  
Vol 16 (2) ◽  
Author(s):  
Ilana Levy ◽  
Samuel Attias ◽  
Lior Cohen ◽  
Nadav Stoppelmann ◽  
Dan Steinberger ◽  
...  
Keyword(s):  
Side Effects ◽  
Postoperative Pain ◽  
Analgesic Effect ◽  
Pain Treatment ◽  
Standard Of Care ◽  
Acupuncture Group ◽  
Controlled Study ◽  
Control Group ◽  
Pain Level ◽  
Randomized Controlled

Abstract Background Postoperative pain is common in patients hospitalized in surgical departments, yet it is currently not sufficiently controlled by analgesics. Acupuncture, a complementary medical practice, has been evaluated for its benefits in postoperative pain with heterogeneous results. We tested the feasibility of a controlled study comparing the postoperative analgesic effect of acupuncture together with standard-of-care to standard-of-care only. Methods In this pilot non-randomized controlled study conducted at a tertiary medical center in Israel, patients received either acupuncture with standard-of-care pain treatment (acupuncture group) or standard-of-care treatment only (control group) following surgery. Visual Analogue Scale (VAS) ratings for pain level at rest and in motion were evaluated both at recruitment and two hours after treatment. Acupuncture-related side effects were reported as well. Results We recruited 425 patients; 336 were assigned to the acupuncture group and 89 to the control group. The acupuncture group exhibited a decrease of at least 40% in average level of pain both at rest (1.8±2.4, p<0.0001) and in motion (2.1±2.8, p<0.0001) following acupuncture, whereas the control group exhibited no significant decrease (p=0.92 at rest, p=0.98 in motion). Acupuncture's analgesic effect was even more prominent in reducing moderate to severe pain at baseline (VAS ≥4), with a decrease of 49% and 45% of pain level at rest and in motion respectively (p<0.001), compared with no significant amelioration in the control group (p=0.20 at rest, p=0.12 in motion). No major side effects were reported. Conclusion Integrating acupuncture with standard care may improve pain control in the postoperative setting.

Outcome of Patients Age 60 and Over with Acute Lymphoblastic Leukemia (ALL) Treated with a Modified Pediatric Protocol

Blood ◽  
2008 ◽  
Vol 112 (11) ◽  
pp. 3962-3962 ◽  
Author(s):  
Susan Kao ◽  
Wei Xu ◽  
Vikas Gupta ◽  
Mark Minden ◽  
Andre Schuh ◽  
...  
Keyword(s):  
Overall Survival ◽  
Side Effects ◽  
Lymphoblastic Leukemia ◽  
Maintenance Phase ◽  
Induction Phase ◽  
Cns Prophylaxis ◽  
Grade 3 ◽  
One Year ◽  
The One

Abstract Acute lymphoblastic leukemia (ALL) in patients over age 60 years is a poor prognosis disease with complete remission rate of 50–60% and median overall survival of less than a year. Between July 2004 and June 2007, we treated 17 elderly patients with newly diagnosed ALL with a modified pediatric protocol that included a remission induction phase, a CNS prophylaxis phase with intrathecal chemotherapy × 4, a 21-week intensification phase (7 cycles × 3 weeks each), and a 72-week maintenance phase. Induction chemotherapy consisted of vincristine 2 mg weekly × 3, doxorubicin 30mg/m2 × 2 doses, methotrexate 40mg/m2 × 1, asparaginase 12,000/m2 U × 1, and dexamethasone 40mg/day × 8 doses; BCR-ABL+ patients received imatinib mesylate 400 mg daily × 16 days instead of asparaginase. The intensification phase consisted of vincristine 2 mg × 7 doses, doxorubicin 30mg/m2 × 7 doses, asparaginase 6000 U/m2 weekly × 21 doses, 6-mercaptopurine 14/21 days, and dexamethasone 6 mg BID × 5/21 days. BCR-ABL+ patients received imatinib 400 mg daily × 14/21 days instead of asparaginase. Maintenance was the same as intensification except that no asparaginase was given. The median age was 66 years (range 60–78 years). Seven patients (41%) were BCR-ABL+ and four (24%) were pre-B with WBC &gt; 30. Major side effects during the induction phase included infection (71%), hyperglycemia requiring insulin (24%), and cardiac toxicity (18%). The complete remission (CR) rate was 71% with an induction mortality of 29%. Of the five induction deaths, four were due to bacterial sepsis or pneumonia, and one was due to tumor lysis syndrome. CNS prophylaxis was well-tolerated except in one patient who required IV hydration for nausea/vomiting. Eleven patients proceeded to intensification. Major side effects during the intensification phase included infections (64%), peripheral neuropathy (64%), thrombosis (27%), and grade 3 nausea/vomiting (27%). Two patients required hospitalization during the intensification phase; there was one myocardial infarction and one acute pancreatitis. Eleven patients proceeded to the maintenance phase; major side effects during maintenance included infections (36%) and grade 3 peripheral neuropathy (18%). Two patients (17%) have relapsed, both during early maintenance phase; both had had a number of dose modifications and delays during intensification. The one year overall survival (OS) was 71% and the median OS has not been reached. After a median follow-up duration of 17 months (range 9–40 months), the median relapse-free survival (RFS) of the CR patients has not been reached; the one year RFS was 82%. These results show that administering a modified pediatric protocol to patients over age 60 years with ALL is feasible with an improved CR rate than generally reported. The OS and RFS also compare favorably to previously reported results, although further follow-up is required. However, induction mortality was high, and infectious complications persisted throughout the entire course of induction and intensification, though much diminished during the maintenance phase. Accrual to the protocol is continuing.

Analysis of overall survival and safety during the course of the phase III VELOUR trial comparing FOLFIRI and ziv-aflibercept or placebo in mCRC patients who progressed on prior oxaliplatin treatment.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. 3574-3574
Author(s):  
Paul Ruff ◽  
Radek Lakomy ◽  
Jana Prausová ◽  
Guy A. Van Hazel ◽  
Vladimir Moiseyenko ◽  
...  
Keyword(s):  
Overall Survival ◽  
Treatment Effect ◽  
Small Proportion ◽  
The United States ◽  
Phase Iii ◽  
Controlled Study ◽  
Single Episode ◽  
Oxaliplatin Treatment ◽  
Grade 3 ◽  
Over Time

3574 Background: VELOUR, a large, international, randomized, placebo (pbo)-controlled study, compared efficacy and safety of FOLFIRI with ziv-aflibercept (known as aflibercept outside the United States) or with pbo in 1,226 metastatic colorectal cancer patients who received prior oxaliplatin treatment. Ziv-aflibercept demonstrated statistically significant, clinically meaningful improvements in median overall survival (OS) (13.5 vs 12.06 mos; hazard ratio [HR]=0.817, P=0.0032), progression-free survival, and response rate. This analysis estimates treatment effect and safety over time course of the study. Methods: HRs by 6-mo time periods were estimated using piecewise Cox proportional hazard model. NCI-CTCAE v3.0 was used to grade adverse event (AE) severity. Results: HR improved over time (Table), consistent with survival curves that continue to separate past the median time point, indicating that the magnitude of ziv-aflibercept treatment effect continues to increase over time. Incidence of grade 3 AEs (45.1% vs 62.0%) was higher in the ziv-aflibercept/FOLFIRI arm; incidences of grade 4 AEs were 17.4% (pbo) vs 21.4% (ziv-aflibercept). More common AEs only occurred in a small proportion of ziv-aflibercept/FOLFIRI cycles (eg, grade ≥3 hypertension and diarrhea occurred in 3.6% and 2.8% of cycles, respectively). The majority of grade 3/4 AEs occurred in early treatment (first 3-4 cycles). Most patients experienced only a single episode of grade ≥3 AEs with ziv-aflibercept/FOLFIRI. Importantly, AEs in VELOUR did not impact patients’ ability to receive chemotherapy. Conclusions: Treatment with ziv-aflibercept/FOLFIRI showed continuous, consistent improvement in OS over time. While combined grade 3/4 AEs were higher with ziv-aflibercept, AEs occurred early in treatment in a small proportion of total cycles; the majority were single-episode in nature. Clinical trial information: NCT00561470. [Table: see text]

Maprotiline (Ludiomil) and Imipramine in Depressed In-Patients: A Controlled Study

1975 ◽  
Vol 3 (6) ◽  
pp. 413-416 ◽  
Author(s):  
W Rieger ◽  
K Rickels ◽  
N Norstad ◽  
J Johnson
Keyword(s):  
Clinical Trial ◽  
Side Effects ◽  
Clinical Efficacy ◽  
Hospitalized Patients ◽  
Strong Tendency ◽  
Controlled Study ◽  
Controlled Clinical Trial ◽  
Randomized Controlled Clinical Trial ◽  
Double Blind ◽  
Randomized Controlled

In this double-blind, randomized, controlled clinical trial of maprotiline ( Ludiomil) against imipramine involving twenty-five newly admitted hospitalized patients, a strong tendency in favour of maprotiline over imipramine emerged. Improvement occurred faster and also at treatment end-point the trend in favour of maprotiline was still to be seen. The slight superiority in clinical efficacy of maprotiline over imipramine was present in both physician and patient measures. Incidences of side-effects were slightly lower for maprotiline than for imipramine.

scholarly journals Analgesic efficacy of nefopam for cancer pain: a randomized controlled study

F1000Research ◽  
2020 ◽  
Vol 9 ◽  
pp. 378
Author(s):  
Koravee Pasutharnchat ◽  
Wichita Wichachai ◽  
Rungrawan Buachai
Keyword(s):  
Placebo Group ◽  
Side Effects ◽  
Cancer Pain ◽  
Breakthrough Pain ◽  
Analgesic Efficacy ◽  
Pain Reduction ◽  
Morphine Consumption ◽  
Controlled Study ◽  
Randomized Controlled ◽  
Significant Pain

Background: Nefopam is a non-opioid, non-steroidal, central acting drug used effectively for postoperative pain. The efficacy of nefopam for cancer pain remains unclear. We aimed to evaluate the analgesic efficacy of nefopam for cancer pain in a randomized controlled trial. Methods: Patients with moderate to severe cancer pain (n=40) were randomly divided into two groups. The nefopam group (n=20) received three 20 mg doses of nefopam every 8 hours. The placebo group (n=20) received normal saline. Intravenous patient-controlled analgesia with morphine was given for breakthrough pain for 48 hours. The primary outcome was significant pain reduction. Secondary outcomes were morphine consumption over 48 hours and incidence of side effects. Results: The nefopam group showed pain reduction at 12 hours (65% of patients), 24 hours (80%), 36 hours (85%), and 48 hours (65%). The placebo group showed pain reduction at 12 hours (70%), 24 hours (75%), 36 hours (80%), and 48 hours (60%). However, there were no statistically significant differences between the groups (p>0.05). The median dosage of morphine consumption in 48 hours was lower in the nefopam group (25.5 mg) compared with the placebo group (37 mg), but this was not statistically significant (p=0.499). There were no statistically significant differences in blood pressure and heart rate between the groups. Side effects in both groups were comparable. Conclusions: At dosage of 60 mg in 24 hours, nefopam did not provide significant pain reduction in moderate to severe cancer pain patients. However, there was a trend of reduced opioid consumption. Further studies with larger sample sizes, longer duration, or higher doses of nefopam are warranted. Registration: Thai Clinical Trail Registry (TCTR) ID TCTR20181016001; registered on 12 October 2018.

Phase III randomized controlled study of daratumumab, bortezomib, and dexamethasone (DVd) versus bortezomib and dexamethasone (Vd) in patients (pts) with relapsed or refractory multiple myeloma (RRMM): CASTOR study.

2016 ◽  
Vol 34 (18_suppl) ◽  
pp. LBA4-LBA4 ◽  
Author(s):  
Antonio Palumbo ◽  
Asher Alban Akmal Chanan-Khan ◽  
Katja Weisel ◽  
Ajay K. Nooka ◽  
Tamas Masszi ◽  
...  
Keyword(s):  
Safety Profile ◽  
Sensory Neuropathy ◽  
Standard Of Care ◽  
Phase Iii ◽  
Randomized Controlled Study ◽  
Controlled Study ◽  
Prior Therapy ◽  
Randomized Controlled ◽  
Grade 3 ◽  
Line Of Therapy

LBA4 Background: Daratumumab (D), a human anti-CD38 IgGκ mAb, induces deep and durable responses with a favorable safety profile in RRMM pts. We report a pre-specified interim analysis of the first randomized controlled study of D (CASTOR; NCT02136134). Methods: Pts with ≥1 prior line of therapy were randomized (1:1) to 8 cycles (q3w) of bortezomib (V)/dexamethasone (d) (V: 1.3 mg/m2sc on Days 1, 4, 8, 11; d: 20 mg po on Days 1, 2, 4, 5, 8, 9, 11, 12) ± D (16 mg/kg iv qw in Cycles 1-3, Day 1 of Cycles 4-8, then q4w until progression). Primary endpoint was PFS. Results: 498 pts (DVd, 251; Vd, 247) were randomized. Baseline demographics and disease characteristics were well balanced. Pts received a median of 2 prior lines of therapy (range 1-10). 66% received prior V; 76% received prior IMiD; 48% received prior PI and IMiD; 33% were IMiD-refractory; 32% were refractory to last line of prior therapy. With median follow-up of 7.4 months, D significantly improved median PFS (61% reduction in risk of progression) and TTP for DVd vs Vd (Table). D significantly increased ORR (83% vs 63%, P <0.0001), and doubled rates of ≥VGPR (59% vs 29%, P <0.0001), and ≥CR (19% vs 9%, P= 0.0012) for DVd vs Vd, respectively; median duration of response was NR vs 7.9 months, respectively. Most common (>25%) AEs (DVd/Vd) were thrombocytopenia (59%/44%), peripheral sensory neuropathy (47%/ 38%), diarrhea (32%/22%) and anemia (26%/31%). Most common grade 3/4 AEs (>10%) were thrombocytopenia (45%/33%), anemia (14%/16%), neutropenia (13%/4%). 7%/9% of pts discontinued due to a TEAE. D-associated infusion-related reactions (45% of pts) mostly occurred during the first infusion; most were grade 1/2 (grade 3/4, 9%/0%). Conclusions: D significantly improved PFS, TTP, and ORR in combination with Vd vs Vd alone. DVd doubled both VGPR and sCR/CR rates vs Vd alone. Safety of DVd is consistent with the known safety profile of D and Vd. The addition of D to Vd should be considered a new standard of care for RRMM pts currently receiving Vd alone. Clinical trial information: NCT02136134. [Table: see text]

Comparison of pre-treatment with low -dose midazolam versus low- dose etomidate for prevention of etomidate induced myoclonus and pain at intubation - A randomized controlled study

2021 ◽  
Vol 19 (1) ◽  
pp. 21-26
Author(s):  
Neha Sharma ◽  
Keyword(s):  
Normal Saline ◽  
Severe Pain ◽  
Statistical Difference ◽  
Low Dose ◽  
Controlled Study ◽  
Group Iii ◽  
Randomized Controlled ◽  
Group I ◽  
Grade 3 ◽  
Group 1

Background: Etomidate a commonly used induction agent in anesthesia is associated with pain and episodes of myoclonus post induction. This study was designed to evaluate and compare Midazolam and low dose of Etomidate in prevention of these symptoms on injection. Methods: This prospective randomized controlled study was conducted on 90 patients allocated to three study groups. Group 1 patients received 0.015 mg/kg of Midazolam i/v diluted to 5 ml in normal saline, Group II received 0.03 mg/kg of Etomidate i/v diluted to 5 ml in normal saline and Group III received 5 ml normal saline intravenously as premedication. Five minutes after receiving the study drugs, patient was preoxygenated with 100% oxygen for 3 min along with anesthesia induction with 0.3 mg/kg etomidate injected intravenously over the period of 20-30 sec. The patients were observed for etomidate induced myoclonus and pain. Results: The incidence of myoclonus in Group II was least with 46.67% having no myoclonus as compared to group I and III where Majority of patients had grade 3 myoclonus (50%; Group I) and (46.67%; Group III). There was statistical difference between the groups in terms of myoclonus grading. Further, there was statistical difference between the groups in pain score with majority of group 1 patients having grade 3 (severe pain = 46.67%) pain and group 3 patients with 43.3% having severe pain. Group 2 on the contrary majorly reported no pain (46.6%). Conclusions: The current study indicated pre induction of etomidate in low dose as an effective strategy in prevention of EIM as compared to Midazolam.

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