Acarbose Add-on Therapy in Patients with Type 2 Diabetes Mellitus with Metformin and Sitagliptin Failure: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study.

BACKGROUND: We evaluated the efficacy and safety of acarbose add-on therapy in Korean patients with type 2 diabetes mellitus (T2DM) who are inadequately controlled with metformin and sitagliptin. METHODS: A total of 165 subjects were randomized to metformin and sitagliptin (Met+Sita, n=65), metformin, sitagliptin, and acarbose (Met+Sita+Acarb, n=66) and sitagliptin and acarbose (Sita+Acarb, exploratory assessment, n=34) therapy in five institutions in Korea. After 16 weeks of acarbose add-on or metformin-switch therapy, a triple combination therapy was maintained from week 16 to 24. RESULTS: The add-on of acarbose (Met+Sita+Acarb group) demonstrated a 0.44%±0.08% (P<0.001 vs. baseline) decrease in glycosylated hemoglobin (HbA1c) at week 16, while changes in HbA1c were insignificant in the Met+Sita group (-0.09%±0.10%, P=0.113). After 8 weeks of triple combination therapy, HbA1c levels were comparable between Met+Sita and Met+Sita+Acarb group (7.66%±0.13% vs. 7.47%±0.12%, P=0.321). Acarbose add-on therapy demonstrated suppressed glucagon secretion (area under the curve of glucagon, 4,726.17±415.80 ng·min/L vs. 3,314.38±191.63 ng·min/L, P=0.004) in the absence of excess insulin secretion during the meal tolerance tests at week 16 versus baseline. The incidence of adverse or serious adverse events was similar between two groups. CONCLUSION: In conclusion, a 16-week acarbose add-on therapy to metformin and sitagliptin, effectively lowered HbA1c without significant adverse events. Acarbose might be a good choice as a third-line therapy in addition to metformin and sitagliptin in Korean subjects with T2DM who have predominant postprandial hyperglycemia and a high carbohydrate intake.

Short-term microcurrent electrical neuromuscular stimulation to improve muscle function in the elderly: A randomized, double-blinded, sham-controlled clinical trial.

BACKGROUND: Microcurrent electrical neuromuscular stimulation (MENS) has been suggested to improve muscle function and restore damaged muscle. However, current evidence is insufficient to determine the effectiveness of this therapy in age-dependent muscle weakness. Therefore, a prospective, randomized, double-blinded, sham-controlled clinical trial was designed to evaluate the effects of short-term MENS on muscle function in the elderly. METHODS: A total of 38 healthy elderly participants aged 65 years and above were enrolled and randomly divided into 2 stimulation groups: real or sham MENS group. Real or sham MENS were applied to the 8 anatomical points of the dominant arm and leg during the course of 40 minutes. We performed muscle function tests at baseline and after the intervention: the handgrip strength tests (HGS, kg), the root mean square values (RMS, µV), and the single leg heel-rise tests (HRT) to determine changes in the strength, activity, and endurance of the elderly muscle, respectively. RESULTS: In the real MENS group, the mean values of the HGS and the number of plantar flexions were significantly increased, but the RMS value of the electromyography signal was significantly decreased after the real intervention (P < .05). However, the sham MENS group showed a significant decrease in the number of plantar flexions and the total time for HRT after the sham stimulation (P < .05). The mean difference in the RMS value was significantly lower, but the number of plantar flexions and the total time for HRT was significantly higher in the real MENS group than in the sham MENS group (P < .05). CONCLUSION: The findings suggest that short-term application of MENS may play a partial role in enhancing physical activities of the elderly, as it can improve some muscle function.

Reversible cerebral vasoconstriction syndrome presenting as subarachnoid hemorrhage: A rare cause of postpartum seizure.

Reversible cerebral vasoconstriction syndrome (RCVS) is a rare cerebrovascular disorder affecting large- and medium-sized arteries, occurring most commonly in young women. Thunderclap headache is the usual primary symptom; seizure is uncommon. During the postpartum period, seizure is a significant concern. The main causes of postpartum seizures are posterior reversible encephalopathy syndrome and cortical venous thrombosis; RCVS-related postpartum seizure is rare. Despite its rarity, its course may be fulminant, resulting in permanent disability or death if the diagnosis is delayed and treatment is not started promptly. We report an unusual case of RCVS presenting as a subarachnoid hemorrhage in a 31-year-old woman admitted for postpartum seizure.

Additional effects of transcranial direct-current stimulation and trigger-point injection for treatment of myofascial pain syndrome: a pilot study with randomized, single-blinded trial.

BACKGROUND: Chronic pain caused by myofascial pain syndrome (MPS) results in generalized and debilitating conditions. Trigger-point injection (TPI) is the mainstay of MPS management to reduce acute and localized pain. Other adjunctive intervention to modulate the central pain pathway might be helpful if they are combined with TPI. Transcranial direct-current stimulation (tDCS), which is a form of neurostimulation, has been reported to be safe and effective in treating chronic pain by changing cortical excitability. OBJECTIVES: To determine whether there is an additional effect of tDCS and TPI to reduce pain in patients with MPS. PATIENTS: Twenty-one patients with newly diagnosed MPS of shoulder girdle muscles. INTERVENTIONS: Patients were randomly assigned into 1 of 3 groups (2 active and 1 sham stimulation groups) and received TPI. Immediately after TPI, tDCS (2 mA for 20 minutes on 5 consecutive days) was administered. For the active stimulation groups, tDCS was applied over 2 different locations (primary motor cortex and dorsolateral prefrontal cortex [DLPFC]). OUTCOME MEASURES: Visual analogue scale (VAS), Pain Threshold Test, and short form of the McGill Pain Questionnaire were measured before and immediately after stimulation for 5 consecutive days. RESULTS: The mean VAS values were decreased in all three groups after 5 days. There was a significant change between before and after stimulation only in the DLPFC group. The significant change in the mean VAS value was shown from after the second stimulation session (p=0.031), and this remained significant until the last stimulation session (p=0.027). CONCLUSION: This study suggests that tDCS over DLPFC may have additional effects with TPI to reduce pain in patients with MPS. tDCS over DLPFC can be used to reverse central pain pathway by modulating cortical plasticity.

A phase II study of docetaxel and oxaliplatin combination in recurrent gastric cancer patients after fluoropyrimidine and/or cisplatin adjuvant treatment: a Korean Cancer Study Group Protocol ST06-02.

BACKGROUND: Surgery alone is no longer an adequate standard of care for patients with resectable gastric cancer. Thus, research efforts should focus on which regimens are the most effective for patients with recurrent gastric cancer after combined treatment with surgery and perioperative or adjuvant chemotherapy. METHODS: Patients with histologically confirmed and measurable advanced gastric cancer who showed a relapse even after fluoropyrimidine and/or cisplatin-based adjuvant chemotherapy received docetaxel (35 mg/m(2)) intravenously on day 1 and 8 plus oxaliplatin (100 mg/m(2)) intravenously on day 1 every 3 weeks until disease progression or unacceptable toxicity. RESULTS: A total of 34 patients with relapsed advanced gastric cancer who had received adjuvant chemotherapy with fluoropyrimidine and/or cisplatin for a median of 6 months (range, 1-48 months) were enrolled in this trial; 22 (64.7 %) patients had been exposed to both agents. Their median age was 58 years (range, 50-68 years). The overall response rate was 55.9 % (95 % confidence interval (CI), 38.3-73.5 %), including 1 complete response and 18 partial responses. At a median follow-up duration of 28.5 months (range, 9.2-50.7 months), the median progression-free survival for all patients was 5.3 months (95 % CI, 4.4-6.1 months) and the median overall survival was 13.8 months (95 % CI, 11.1-16.4 months). The most common grade 3 or 4 hematologic and nonhematologic toxicities were neutropenia (47.1 %) and diarrhea (17.6 %), respectively. Five patients (14.7 %) experienced febrile neutropenia. CONCLUSIONS: Docetaxel and oxaliplatin combination chemotherapy was active and tolerable in patients with recurrent gastric cancer after fluoropyrimidine and/or cisplatin-based adjuvant chemotherapy.

Phase I dose-finding study of sorafenib in combination with capecitabine and cisplatin as a first-line treatment in patients with advanced gastric cancer.

BACKGROUND: To define maximum-tolerated dose (MTD), dose-limiting toxicities (DLTs), and preliminary efficacy of sorafenib plus capecitabine/cisplatin in advanced gastric cancer (AGC) patients. METHODS: Four dose-level combinations were tested in a standard 3 + 3 dose escalation design. Level 1: sorafenib 400 mg/d, capecitabine 1,600 mg/m(2)/d, cisplatin 80 mg/m(2). Level 2: sorafenib 800 mg/d, capecitabine 1,600 mg/m(2)/d, cisplatin 80 mg/m(2). Level 3: sorafenib 800 mg/d, capecitabine 2,000 mg/m(2)/d, cisplatin 80 mg/m(2). Level 1A: sorafenib 800 mg/d, capecitabine 1,600 mg/m(2)/d, cisplatin 60 mg/m(2). RESULTS: There were 1 DLT at Level 2, and 2 DLTs at Level 3 (Level 3 was MTD). Since the relative dose intensity (RDI) of sorafenib and capecitabine could not be maintained at Level 2, Level 1A was newly investigated. As no DLT was observed and RDI remained above 80%, Level 1A is the recommended dose for the next clinical trial. Objective response rate was 62.5% (10 of 16 patients, 95% CI; 38.8-86.2%). Median progression-free survival and overall survival were 10.0 months (95% CI; 7.4-13.8) and 14.7 months (95% CI; 12.0-20.0), respectively. CONCLUSIONS: Sorafenib 400 mg bid daily, capecitabine 800 mg/m(2) bid (days 1-14), and cisplatin 60 mg/m(2) (day 1) is recommended for further development in AGC.