BACKGROUND/AIMS: Decreasing trend of eradication rate of H. pylori using first-line triple regimens (proton pump inhibitor, amoxicillin, clarithromycin) has been issued. Longer therapies may become more popular if there are better results. Recent eradication rate should be examined and proper recommendation should be timely done according to the result. METHODS: We examined recent eradication rates of first-line triple regimens and compared eradication rate according to the duration of this first-line therapy for H. pylori infection. The 976 patients received first-line triple therapy at the single center from November, 2005 to October, 2009 were retrospectively analyzed. Urea breath test was done at four to six weeks after completion of eradication therapy. RESULTS: Overall eradication rate of triple regimen by intention to treat analysis was 80.4% (785/976). One week eradication rate has decreasing trend and below 73.3% during recent 2 years. Eradication rate in 2 weeks group (83.3%, 165/198) was significantly higher than 1 week group (73.3%, 198/270) from November, 2007 to October, 2009 (p<0.01). CONCLUSIONS: Our results showed that 2 weeks triple regimen should be preferred as first-line therapy for H. pylori eradication.
Amoxicillin ; Breath Tests ; Helicobacter pylori ; Humans ; Intention to Treat Analysis ; Retrospective Studies ; Urea

BACKGROUND: Lamotrigne (LTG) is a newly developed antiepileptic drug which has shown to'be effective for medically intractable partial seizures. LTG was recently introduced to Korea but its clinical efficacy has not been investigated yet. METHODS: We assigned 34 medically intractable localization related epileptic patients taking maximally tolerable dose of carbarmazepine(CBZ). The study protocol consisted of 12 weeks of baseline phase, 4 weeks of phase I (drug -adjustment phase) and 8 weeks o f phase II (maintenance of LTG 200mg/day) After phase II, eligible patients entered into long-term therapy. Two patients dropped out during phase II for adverse event (AE) in one, and AE and poor seizure control in the other. RESULTS: Intention to treat analysis of the seizure outcome after 12 weeks of LTG add-on therapy showed mean seizure frequency reduction of 23.6% (p=O.006). More than 50% seizure frequency reduction was seen in 9 of 34 patients (26.4%), which was comparable to the results of previous clinical trials. On the other hand, the incidence of AE were quite high, which was developed in 27 patients. Dizziness with or without blurred vision and/or diplopia were the most common AE and occurred in 64.7%, which improved promptly by either reduction of CBZ or LTG doses. Twenty-two patients entered into long-term therapy and 18 patients showed either maintenance or more. LTG add-on therapy did not show any significant alterations of baseline Lab. Tests. DISCUSSION: LTG was an effective and safe new antiepileptic drug. However, about two-third of our patients developed A. E. similar to CBZtoxicity, which should be carefully considerd for treating patients taking maximally tolerable CBZ therapy. The proportion of patients taking LTG 300mg/day or more was very low in this study, which suggested the racial difference of tolerability to LTG.
Carbamazepine* ; Diplopia ; Dizziness ; Hand ; Humans ; Incidence ; Intention to Treat Analysis ; Korea ; Seizures

OBJECTIVE: To establish the effectiveness and safety of topical aspirin on patients with persistent lichen simplex chronicus (LSC) despite corticosteroid therapy
METHODS: Fifty-four male and female patients with LSC who underwent topical corticosteroid therapy in the past were randomized to receive 3 percent aspirin ointment for two weeks followed by placebo ointment for two weeks or placebo first followed by aspirin with a crossover design after a 2-week washout period on a preselected involved area. Outcomes looked for were pruritus by visual analogue scale (VAS), activities of daily living score (ADLS), size of lesion, number of skin markings and photographic assessment score (PAS). All comparisons were done both on per protocol and intention-to-treat bases.
RESULTS: Data were complete for 42 (77.8 percent) subjects. On per protocol analysis, there were significantly greater reductions in lesion size and number of skin markings on aspirin use than on placebo use (p=0.005 and p0.001, respectively). Proportions of subjects with improved signs and symptoms were all significantly greater in the aspirin group than in the placebo group (69 percent versus 9.5 percent by VAS, 85.7 percent versus 19 percent by ADLS and 100 percent versus 4.8 percent by PAS; all 0.001). Intention-to-treat analysis of the results had similar findings. One adverse event of transient burning sensation after topical aspirin use was reported.
CONCLUSION: Topical aspirin can be safely used for two weeks and is significantly more effective than topical placebo in decreasing pruritus and impairment of activities of daily living, as well as in improving the size and morphology of LSC lesions.

Human ; Male ; Female ; Aged ; Middle Aged ; Adult ; Adrenal Cortex Hormones ; Aspirin ; Intention To Treat Analysis ; Neurodermatitis ; Ointments ; Pruritus ; Sensation ; Skin Diseases

BACKGROUND/AIMS: The Helicobacter pylori (H. pylori) eradication rate of standard triple therapy is unsatisfactory in Korea, and sequential therapy (SQT) has been suggested to be a practical first-line alternative regimen. The aim of this prospective study was to document changes in annual eradication rates of SQT. METHODS: A total of 983 H. pylori-positive subjects were enrolled from 2010 to 2018 and their data were subjected to intention-to-treat (ITT) and per-protocol (PP) analysis. All subjects received 10-day sequential therapy consisting of 40 mg esomeprazole and 1 g amoxicillin b.i.d for 5 days followed by 40 mg esomeprazole b.i.d, 500 mg clarithromycin b.i.d and 500 mg metronidazole t.i.d for 5 days. The 13C-urea breath test, rapid urease test (CLO test®), and histology were used to confirm eradication. Compliance and side effects were also investigated. RESULTS: ITT and PP eradication rates of SQT were 69.9% (687 of 983) and 87.1% (657 of 754), respectively. The annual eradication rate of ITT remained consistent over the 8-year study period (p for trend=0.167), whereas PP analysis showed the eradication rate increased (p for trend=0.042). The overall adverse event rate for SQT was 41.7% (410 subjects). CONCLUSIONS: Despite high antibiotic resistance rates in Korea, the eradication rate of SQT did not decrease over the 8-year study period.
Amoxicillin ; Breath Tests ; Clarithromycin ; Compliance ; Drug Resistance, Microbial ; Esomeprazole ; Helicobacter pylori ; Helicobacter ; Intention to Treat Analysis ; Korea ; Metronidazole ; Prospective Studies ; Urease

Evaluation of scientific evidence in the medical literature is based on the research methodology, which can be the fundamental tool for medical professionals to improve their practice. Since analytic studies usually provide evidence for generating hypotheses and selecting appropriate research designs, this article aims to review the methods for evaluating the study quality in randomized controlled trials (RCTs), cohort studies, and case-control studies. Critical appraisal of systematic errors including selection bias, performance bias, attrition bias, detection bias, and publication bias are the essential elements of the evaluation. Clinical trials need to have an adequate description of sequence generation and allocation concealment, blinding for exposure measurement, completeness of follow-up and intention to treat analysis, and blinding for outcome evaluation. For cohort studies, like RCTs, appropriate control of confounding variables is needed to prevent selection bias, and blinding and completeness of follow-up are also very important. Matching of the case group to the control group, blinding of interviewers, and proper definition of the cases and controls are important to prevent bias in a case-control study. Since the process of critical appraisal depends on the quality of reporting, there have been efforts to improve the reporting quality of the medical literature. However, reporting all of the elements necessary to avoid bias does not automatically guarantee an exclusion of bias or the quality of a study; instead, what is important is the logical connection of the elements of a study and the eventual lucid expression of the elements.
Bias (Epidemiology) ; Case-Control Studies ; Cohort Studies ; Confounding Factors (Epidemiology) ; Follow-Up Studies ; Intention to Treat Analysis ; Logic ; Preventive Medicine ; Publication Bias ; Research Design ; Selection Bias

PURPOSE: A single institute trial of combination chemotherapy, with paclitaxel and cisplatin, in patients with metastatic breast cancer, having failed previous combination chemotherapy, was performed. MATERIALS AND METHODS: Patients were only eligible for this study if there disease had progressed, following treatment with previous chemotherapy, in either an adjuvant or a metastatic setting. Paclitaxel 175 mg/m2 was administered as a 3-hour continuous infusion on day 1, and cisplatin 80 mg/m2 was administered for 2 hours on day 2, with adequate hydration. This was repeated every 3 weeks, and continued until one of the following events occurred: disease progression, unacceptable adverse effect or treatment refusal by the patient. Intercurrent palliative radiotherapy, or concurrent hormonal therapy, was permitted, depending on each patient's status. All the endpoints were evaluated under the principle of intention to treat analysis. RESULTS: A total of 24 patients entered the study, and 18 had at least one measurable lesion, but 6 did not. The objective response rate of the 18 patients was 50%(9/18). Two were complete responses and seven showed partial responses. The median response duration, progression free and overall survival were 5.3 months (range, 4~18), 6 months (95% CI, 5~7) and 12 months (95% CI, 7~17), respectively. 67% of the planned dose was administered. Out of a total 135 cycles administered, about 20% of cycles showed grade 3 or 4 leukopenia and 7% showed grade 3 thrombocytopenia. Two patients suffered from pneumonia, and one experienced neutropenic fever. Mucositis, greater than grade 3, existed in three cases. No treatment related deaths were reported. CONCLUSION: The combination chemotherapy, with paclitaxel and cisplatin, was active in the treatment of metastatic breast cancer patients having failed previous chemotherapy.
Breast Neoplasms* ; Breast* ; Cisplatin* ; Disease Progression ; Drug Therapy ; Drug Therapy, Combination* ; Fever ; Humans ; Intention to Treat Analysis ; Leukopenia ; Mucositis ; Paclitaxel* ; Pneumonia ; Radiotherapy ; Thrombocytopenia ; Treatment Refusal

INTRODUCTION:Radioactive iodine(I131) therapy is an established definitive treatment for Graves' hyperthyroidism.However,the optimal method of determining the radioiodine treatment dose remains controversial.
OBJECTIVE: To compare the efficacy of fixed dose versus  calculated  dose  regimen  in  the  treatment  of  Graves'  hyperthyroidism  among  Filipinos 
METHODOLOGY: Diagnosed   Graves'   disease   patients underwent  thyroid  ultrasound  to  estimate  thyroid  size. Patients  were  randomized  to  either  fixed  or  calculated dose  of  radioiodine  treatment.  For  fixed  dose  group,the  WHO  goiter  grading  was  utilized:  Grade   0   (5mCi),  Grade   1  (7mCi),  Grade2  (10mCi),  Grade  3  (15mCi).  For calculated  dose  group  the  following  formula  was  used:
                    Dose(mCi)= 160uCi/g thyroid x thyroid gland weight in grams x 100  /  24-hour RAIU(%)
Thyroid function test (TSH,FT4)  was monitored every  three  months  for  one  year. 
RESULTS: Of  the  60  patients  enrolled,  45  (fixed  dose;  n= 27,  calculated  dose;  n=  18)  completed  the  six  months follow-up  study.  Analysis  was  done  by  application  of  the  intention-to-treat  principle.  The  percentage  failure  rate  at  third  month  in  the  fixed  vs.  calculated  dose  group  was:  26  v.  28%  with  a  relative  risk  (RR)  value  of  0.93.  At  six  months  post-therapy,  there  was  a  noted  reduction  in  the  failure  rates  for  both  study  groups  (11  vs.  22%,  respectively),  with   a   further   reduction   in   the   relative   risk   value (0.67),  favoring  the  fixed  dose  group.
CONCLUSION: Fixed   dose   radioiodine   therapy   for Graves'   disease   is   observed   to   have   a   lower   risk   of   treatment   failure   (persistent   hyperthyroidism)   at   three  and  six  months  post-therapy  compared  to  the calculated  dose.

Human ; Male ; Female ; Middle Aged ; Adult ; Iodine Radioisotopes ; Iodine ; Intention To Treat Analysis ; Graves Disease ; Hyperthyroidism ; Goiter ; Thyroid Function Tests ; Treatment Failure

OBJECTIVETo investigate the effects of Qingre Huoxue Decoction , clearing heat and promoting blood flow; QRHXD), on the radiographic progression in patients with rheumatoid arthritis (RA) by X-ray imaging.

METHODSEighty-six patients with active RA diagnosed as damp-heat and blood stasis syndrome were randomized into a QRHXD group and a QRHXD plus methotrexate (MTX) group, with 43 cases in each group. After one-year of treatment, 21 cases in each group (42 in total) were evaluated. Radiographs of hands were obtained at the baseline and after 12 months of treatment. Images were evaluated by investigators blinded to chronology and clinical data, and assessed according to the Sharp/Van der Heijde methods.

RESULTSHigh intrareader agreements were reached (mean intraobserver intraclass coefficients: 0.95). No significant change in any imaging parameters of joint destruction was observed at 12 months in either group; and the differences between the two groups were not significant (P>0.05). The mean of the changing score in the QRHXD group was 3.5 ± 4.1, and 2.4 ± 3.5 in the QRHXD+MTX group, while the baseline radiographic score of patients in the QRHXD group was relatively higher (18.9 ± 19.1 vs. 14.0 ± 14.0). The mean rates of the changing scores of the two groups were similar (0.24 ± 0.28 vs. 0.25 ± 0.44, P=0.40). The severity of progression in the two groups was also similar (P=0.46), 7 cases without radiographic progression in the QRHXD group and 8 in the QRHXD+MTX group, 3 cases with obvious radiographic progression in the QRHXD group and 1 in the QRHXD+MTX group.

CONCLUSIONRadiographic progression of RA patients in both groups is similar, indicating that the QRHXD Decoction has a potential role in preventing bone destruction.

Adult ; Arthritis, Rheumatoid ; diagnostic imaging ; drug therapy ; Disease Progression ; Drugs, Chinese Herbal ; therapeutic use ; Female ; Humans ; Intention to Treat Analysis ; Male ; Methotrexate ; therapeutic use ; Middle Aged ; Radiography

OBJECTIVETo examine the efficacy and safety of bathing therapy with Taohong Siwu Decoction (, TSD) in the treatment of early-stage, mild-moderate diffuse cutaneous systemic sclerosis (dcSSc).

METHODSThis randomized, placebo-controlled trial enrolled 148 men and women (18-60 years) with dcSSc (disease duration 12 months) and baseline modified Rodnan skin score (MRSS) 10. Patients were randomized into a TSD group (71 cases bathing with TSD plus oral prednisone) or control group (71 cases bathing with placebo plus oral prednisone). Bathing (40 °C, 30 min) of the upper and lower limbs was carried out once daily for 12 consecutive weeks. The primary outcome measure was MRSS; secondary outcomes were Raynaud's phenomenon (RP) score, quality of life (QOL), physician visual analogue scale (VAS), patient VAS, percent predicted diffusing capacity for carbon monoxide (DLCO), percent predicted forced vital capacity (FVC), erythrocyte sedimentation rate (ESR), C-reactive protein (CRP) level and overall treatment effect.

RESULTSThe final analysis included 135 patients (control group, 68 cases; TSD group, 67 cases). Primary and secondary outcome measures after 2 weeks of treatment showed no improvement (versus baseline) in both groups, with no differences between groups. At 12 weeks, QOL, physician VAS, patient VAS, ESR and CRP were improved in both groups, but MRSS and RP score were improved only in the TSD group (all P<0.05). MRSS, RP score, QOL, physician VAS, patient VAS, ESR and CRP differed significantly between groups (all P<0.05). Meanwhile, the overall treatment effect was significantly higher in the TSD group than in the control group (P<0.05). Adverse events in the two groups were similar (P>0.05).

CONCLUSIONSBathing with TSD plus oral prednisone achieves better outcomes than oral prednisone alone in patients with dcSSc and is not associated with serious adverse events.

Adult ; Drugs, Chinese Herbal ; adverse effects ; therapeutic use ; Female ; Humans ; Hygiene ; Intention to Treat Analysis ; Male ; Middle Aged ; Outcome Assessment (Health Care) ; Placebos ; Scleroderma, Diffuse ; drug therapy ; Treatment Outcome

BACKGROUND/AIMS: Proton pump inhibitors (PPIs) act by irreversibly binding to the H+-K+-ATPase of the proton pump in parietal cells and may possibly affect the vacuolar H+-ATPase in osteoclasts. METHODS: We investigated the effect of 8 weeks of PPI treatment on the parameters of bone turnover and compared PPI with revaprazan, which acts by reversibly binding to H+-K+-ATPase in proton pumps. This study was a parallel randomized controlled trial. For 8 weeks, either a PPI or revaprazan was randomly assigned to patients with gastric ulcers. The parameters of bone turnover were measured at the beginning of and after the 8-week treatment period. RESULTS: Twenty-six patients (PPI, n=13; revaprazan, n=13) completed the intention-to-treat analysis. After the 8-week treatment period, serum calcium and urine deoxypyridinoline (DPD) were increased in the PPI group (serum calcium, p=0.046; urine DPD, p=0.046) but not in the revaprazan group. According to multivariate linear regression analysis, age > or =60 years was an independent predictor for the changes in serum calcium and urine DPD. CONCLUSIONS: In elderly patients, administering a PPI for 8 weeks altered bone parameters. Our study suggested that PPIs might directly alter bone metabolism via the vacuolar H+-ATPase in osteoclasts.
Aged ; Amino Acids/drug effects/urine ; Bone Remodeling/*drug effects ; Bone and Bones/*metabolism ; Calcium/blood ; Female ; Humans ; Intention to Treat Analysis ; Linear Models ; Male ; Middle Aged ; Multivariate Analysis ; Osteoclasts/*metabolism ; Prospective Studies ; Proton Pump Inhibitors/*pharmacology ; Pyrimidinones/*pharmacology ; Tetrahydroisoquinolines/*pharmacology