General Improvement Rate Research Articles

Application of Manuka honey in treatment patients with GERD.

Gastro-esophageal reflux disease has systematically increase in Western countries over recent years. Health benefits of Manuka honey allows to use it for medical purposes, for example reduction of inflammation of gastrointestinal mucosa. Thus, the aim of research was the application of Manuka honey in treatment patients with Gastro-esophageal reflux disease (GERD). The study was conducted on a group of 30 patients, which consumed Manuka honey or placebo for a period of 4 weeks. The gastroscopy and histology has been made twice, that is before and after experiment. Furthermore, the symptoms reports and nutritional interviews have been collected. The endoscopical examination showed that in Manuka group the improvement was 73.3%. In the sub-groups of esophagitis-A and esophagitis-B the improvement rate was 81.8%, and 50%, respectively. However, in the placebo group, the general improvement rate was much lower. The results have been confirmed in the histopathological examination. Moreover, it is worth noticing, that in sub-group declaring non-medication, the improvement was only for patients consuming Manuka honey. Changes of symptoms in subjective assessment of patients were evaluated after 2 and 4 weeks. The improvement rate in Manuka group was 86.7% and 100%, while in Placebo group it was only 26.7% and 40%, respectively. Manuka honey seems to be effective in GERD, which have been confirmed by subjective feelings of patients and by endoscopic and histopathologic examination. Our research is a pilot study before administration of Manuka honey to larger population. The results are promising and may facilitate the quality of life of patients with GERD.

The Treatment Strategy for Diabetes Mellitus by Kampo Medicine

Recently in Japan, the numbers of diabetic patients have been increased to 7.4 million and to 16.2 millions if the subjects of impaired glucose tolerance are added. Most Japanese diabetic patients are type 2 (non-insulin dependent). Decreased secretion of insulin and insulin resistance play important roles on the occurrence and progression of type 2 diabetes.Long-established systems of traditional medicine have evolved from systematic recordings of human evidence for more than 3 thousands years. In addition the traditional Chinese medicinal philosophy is one of the oldest medical sciences in the world and has a long-standing history in the usage of herbal medicinals. Nowadays the use of complementary/alternative medicine and especially the consumption of botanicals has been increasing rapidly worldwide.1. Clinical StudiesThe management of diabetic neuropathy is one of the most difficult clinical problems. Among 65 patients with diabetic neuropathy who suffered from numbness of lower extremities 43 (66.2%) experienced some degree of improvement after oral administration of Goshajinkigan (GJG). Following our first report, more than 10 papers were published in Japan and almost same results were obtained. In a well-controlled comparative study, the efficacy of GJG and mecobalamin in diabetic neuropathy was estimated. After oral administration of GJG, the general improvement rate was 80.0%, while it was 48.1% in mecobalamin. The difference between the two groups was statistically significant (P<0.01). These results suggested that GJG is a useful medicine for amelioration of numbness due to diabetic neuropathy.2. Animal experimental studiesRegular physical training has been known to be beneficial in the prevention and the treatment of life-style related diseases such as type 2 diabetes. However, it is very difficult for diabetic patients to continue physical exercise training for a long time. Troglitazone has insulin-sensitizing actions but it withdrew because of severe fatal hepato-toxic actions. Therefore development of insulin-sensitizing medicine without significant side-effects have been expected.Chinese herbal medicine has less frequent side effects when compared to modern western medicine.In the present study, the effect of GJG on insulin resistance in streptozotocin (STZ, 50mg kg-1 BW, ivy.)-induced diabetic rats was examined by means of the euglycemic clamp procedure.The improvement of impaired insulin action in STZ-diabetic rats by single and repeated administration of GJG may be due, at least in part, to enhance insulin signaling, and subsequent ameliorated production of NO. In conclusion, (1) Diagnosis and primary treatment to reduce blood glucose including diet, exercise, oral hypoglycemic agents and insulin should be practiced by western style medical sciences. (2) Kampo medication is useful for the prevention and treatment of diabetic complications. (3) Kampo medicine has the possibility of prevention of type 2 diabetes.

Results of surgical treatment for lumbar canal stenosis due to degenerative spondylolisthesis: enlargement of the lumbar spinal canal

The purpose of this retrospective study was to analyze clinical results and radiographic findings in patients who underwent surgical enlargement of the lumbar spinal canal combined with resection of the posterosuperior margin underneath the slipping vertebral body for the treatment of lumbar canal stenosis due to degenerative spondylolisthesis. A series of 64 patients who were observed for 3 years or more after operation were examined. The mean age at the time of operation was 64.2 years. The follow-up period was 3–17 years. The Japanese Orthopaedic Association (JOA) score increased from 14.9 points before operation to 25.4 points at the time of the study on average. The general improvement rate was 75.6%. The height and range of motion of the enlarged intervertebral disc were mildly to moderately decreased, and it was found there was a small effect on the adjacent intervertebral disc. On computed tomography, the total level of the enlarged region of the posterosuperior margin increased from 184.4mm2 to 339.1mm2 on average, but the area of the resected region was 163.3mm2 and accounted for 48% of the postoperative area of the spinal canal in the posterosuperior margin. This enlargement of the spinal canal was maintained along the dural canal, and physiological morphology was established. By surgically enlarging the lumbar spinal canal combined with resecting the posterosuperior margin underneath the slipping vertebral body, concomitant repositioning or spinal fixation was unnecessary.

菌状息肉症に対するガンマーインターフェロン療法における全国多施設調査報告

“Multi-Center Clinical Trial of IFN-γ on Mycosis Fungoides in Post-Marketing Surveillance”A clinical trial was performed at 36 institutes to investigate the efficacy and safety of IFN-γ (Biogamma®) in 69 patients with mainly CTCL.The general improvement rate (CR and PR) was 37.7%, which was lower than that of phase II trials, which was 60.7%. This may be explained by the fact that the present study had about twice as many patients in advanced stage of the disease, such as tumor phase, than phase II.Patients administered 2million JRU of IFN-γ over 12 weeks showed the high improvement rate.Adverse effects and their frequency were almost same as those in premarketing clinical trials.Patients receiving a combination therapy, such as IFN-γ and PUVA, showed lower improvement rate as compared with those treated with IFN-γ alone. As much severe patients were assigned to the combination therapies, the improvement rate was considered lower in this group than others. More effective combination therapies must therefore be explored for patients in more advanced stages of CTCL.

ザルトプロフェン（ペオン錠８０）の炎症組織移行性

Administation of non-steroidal anti-inflammatory drugs (NSAIDS) can cause adverse reactions, particularly gastric problems. Methods to ameliorate these adverse reactions have been suggested, such as use of selective cyclo-oxygenase-2 (COX-2) inhibitors, use of NSAID prodrugs, and development of agents with inflammatory tissue selectivity.The present study of zaltoprofen, a selective COX-2, inhibitor investigated the drug level in synovial fluid as well as its efficasy and safety.We measured the zaitoprofen concentration in the blood and synovial fluid of patients with osteoarthritis of the knee at two and four weeks after drug administration. The blood levels at and 4 weeks were 3.43 and 2.69 μg/m1, respectively, while the synovial fluid levels were 1.0 and 1.0μg/ml, respectively, The percent transfer to synovial fluid was 29.1% and 35.7% respectively.The final general improvement rate was 40%, and neither adverse reactions nor abnormal laboratory test results were detected in any patient.

慢性関節リウマチに対するジクロフェナクナトリウムの徐放性カプセルと坐剤との併用療法における有効性と安全性の検討 Ｑｕａｌｉｔｙ ｏｆ Ｌｉｆｅの評価を含めて

In the current treatment of rheumatoid arthritis (RA), to achieve the high quality of life (QOL) of patients became important. Therefore, we assessed QOL as well a the efficacy and safety in the combined therapy of diclofenac sodium slow release capsule (Voltaren SR capsule) and suppository (Voltaren SUPPO) .To 70 RA patients, slaw release capsule 37.5 mg was given orally twice daily I capsule each after breakfast and dinner, and 25 mg p.r. of suppository before sleep for 8 weeks, respectively.Among the inflammatory findings, significant improvement was seen in the number of painful joints and painful/swollen joints after week 4 and 8 of the treatment.There was no change in QOL evaluated using modified health assessment questionnaire (HAQ), quality of well-being score face scale and analogue scale evaluation method developed by us The results of HAQ stratified by the various factors showed improvement in the groups of“No treatment history with NSAIDs”in week 4 and more serious cases of“Stage”and“Pre-administration MHAQ value”.The final general improvement rate was 20.8% (10/48) for“moderate improvement”or better, and 60.4% (29/48) for“slight improvement”or better.Adverse effects were seen in 7 patients among 61 (11, 5%) . Symptoms were mild except for moderate epigastric pain.From the above, the usefulness of the present therapy was confirmed as high as that of the double blind test of slow release capsule. The short-term efficacy of the present therapy was also suggested by some QOL measures, especially in serious RA patients. However, we think that further studies using controlled test with sufficient number of natients are necessary to confirm these findings.

アゼラスチンのアレルギー性鼻炎への効果 奈良県下多施設共同研究

The effects of azelastine were investigated in 23 patients with perennial and 57 with seasonal allergic rhinitis seen in our institutions between October 1986 and April 1988. The antigen in seasonal allergic rhinitis was identified as Japanese cedar pollen in 45 patients and cock's footgrass in 12.1. In the rating general improvement of the response was classified as moderate or better in 47.8% of those with perennial rhinitis and as slight or better in 82.6%. The corresponding values for seasonal rhinitis were 57.9% and 84.2%. The combined ratings were 55.0% and 83.8%, respectively.2. Treatment reduced the following symptoms: sneezing, nasal secretions, nasal obstruction, disturbances in daily living, and volume of secretion.3. Japanese cedar pollinosis was treated in 25 patients in 1987 and in 20 in 1988. The general improvement ratings were 40.0% and 68.0% in 1987 and 75.0% and 95.0% in 1988. Considering that in 1988 the Japanese cedar pollen count was four times that in 1987 the difference in the general improvement rating between the two years may be due more to the duration of treatment than to the pollen count.4. Drowsiness as an adverse reaction was noted in 4 of the 80 patients, and treatment was discontinued in one.5. In general utility the drug's usefulness was rated as moderate or better in 47.8% of the perennial rhinitis patients and as slight or better in 78.3%. The corresponding values for the seasonal rhinitis patients were 57.9% and 84.2%, respectively. The general utility ratings for both types combined were 55.0% and 82.5%.

鼻アレルギーに対するアゼプチンの臨床検討 香川県多施設共同臨床研究成績

Azeptin® was administered to 48 patients with perennial allergic rhinitis for prolonged periods to determine its efficacy and safety.1) The rate of improvement, as determined by a final general improvement rating, was 60.5% when “moderately improved” or better evaluations were included. The rate of usefulness was 66.0% when “moderately or more useful” evaluations were included.2) The rate of improvement, as determined by a general improvement rating for subjective symptoms, was 61.4% when “moderately improved” or better evaluations were included. The rate of disappearance was high for sneezing (82.2%), nasal discharge (66.7%), and nasal obstruction (46.7%).3) The rate of improvement, as determined by a general improvement rating for objective symptoms, was 56.8% when “moderately improved” or better evaluations were included.4) The side effect elicited in this study was mild sleepiness which was experienced by one patient. This symptom disappeared without any particular procedure, although the drug was continued.In conclusion, Azeptin®, even when administered for extended periods of time, can maintain its beneficial effect on perennial allergic rhinitis, with safety as evidenced by only mild side effects. It is concluded that Azeptin® is a very useful drug.

Dose Finding Study of Bucumolol in Angina Pectoris and Arrhythmias

In order to find out an appropriate therapeutic dose of bucumolol, a newly developped β-blocker, the effects of 30mg/day and 60mg/day of the drug on angina pectoris and arrhythmias were studied by means of double blind group comparison method.Of 66 patients with angina, general improvement rating was better in 28cases of 30mg/day group than in 38cases of 60mg/day group (P=0.085), while no signifi-cant difference in usefulness was observed between two groups.The rates of decrease of the anginal attacks and nitroglycerin consumption were higher in the former group (P=0.053 and P=0.024).Of 46 patients with premature beats, general improvement rating and usefulness were significantly better in 24 cases of 30 mg/day group (P=0.025 and P=0.027), but no significant difference was seen in the rate of decrease of premature beats between two groups.The incidence of side effects was 18 among 132 cases (13.6%).These data indicate that 30 mg/day of bucumolol is recommended for the treatment of angina and arrhythmias.

A Double Blind Controlled Study on the Clinical Effects of Methylprednisolone Sodium Succinate in Shock as Compared with Hydrocortisone Sodium Succinate

The effects of methylprednisolone sodium succinate (Solu-Medrole®) in shock were studied by the double blind technique at 32 medical centers, using hydrocor. tisone sodium succinate (Solu-Cortef®) as the active control drug. Either methylprednisolone sodium succinate or hydrocortisone sodium succinate was administered in an initial dose of 20-30 mg per kg of body weight to each of 135 patients. Any patients who failed to respond well to the initial doses were given additional doses. The effects of the steroids used were evaluated within 12 hours following the final doses.The results obtained are as follows:1. The general improvement rate was higher for the methylprednisolone sodium succinate group than for the hydrocortisone sodium succinate group.2. The global utility rate was greater for the methylrednisolone sodium succinate group than for the hydrocortisone sodium succinate group.3. Methylprednisolone sodium succinate group showed a greater improvement than the hydrocoritsone sodium succinate group in the post-treatment measurements of shock score, systolic blood pressure, pulse pressure, shock index, urinary output, arterial blood pH and Base Excess.

Clinical Evaluation of 5-Hydroxy-L-Tryptophan as an Antidepressant Drug

Effectiveness of 5-hydroxy-L-trytophan as an antidepressant drug was studied with 59 patients with depressive symptoms using Rating Scale for Depression made by Clinico-Psychopharmacology Research Group in Japan for a preparatory step of a double blind clinical study of 5-hydroxy-L-tryptophan treatment of depression. A daily dose of 150--300 mg of 5-hydroxyl-L-tryptophan was administered for three weeks. Favorable responses were observed in 40 patients (67.8%), of whom 13 patients were markedly improved. These effects were noticed in 32 patients (80% of the improved patients) within a week of the treatment. Analysis of General Improvement Rating in the various subtypes of depressive symptoms indicated that endogenous depression and involutional or senile depression were the preferable indication of 5-hydroxy-L-tryptophan loading. The main side effects of 5-hydroxy-L-tryptophan were gastrointestinal disturbances which were minimized by the simultaneous administration of metoclopromide or trihexyphenidyl.

The Comparison of Therapeutic Effects of FK-880 (Sulpiride) and Perphenazine in Schizophrenia by A Double-blind Controlled Study

The authors carried out a pilot study on therapeutic effectiveness of sulpiride mainly in the treatment of schizophrenia. The results of this study were already published (Journal of New Remedies & Clinics 22 ; 29, 1973). This paper presents the effect of sulpiride on schizophrenia by a double-blind controlled study compared with perphenazine, an established standard neuroleptic. The subjects enrolled were 64 hospitalized chronic schizophrenics, who were divided into two groups and daily given4-10 tablets of either sulpiride (100mg/Tab.) or perphenazine (3mg/Tab.) for a period of 6 weeks. During this period, 9 patients, 5 receiving sulpiride and 4 receiving perphenazine, dropped out. The global comparative judgement after the treatment for 6 weeks revealed statistically no significant difference in the therapeutic effects between both drug groups by a sequential analysis. The general improvement rating after the treatment for 6 weeks revealed that the slight or more improvement was observed in 44.4% of patients given sulpiride and 55.2% of patients given perphenazine, while the moderate or more improvement was observed in 29.6% and 13.8%, respectively. In patients suffering from schizophrenia for over 5 years, sulpiride showed significantly more favourable effect than perphenazine (P<0.05). This result suggests that sulpiride could be also favourably effective in the treatment of chronic schizophrenia. In the items of the three universities' rating scale, perphenazine made significantly higher improvement in hallucination than sulpiride (P<0.05) 4 and 6 weeks after initiation of the treatment. In the incidence of side effects, no significant difference was observed between the two groups. In the laboratory tests performed in all the patients no contributory abnormal findings were obtained.

A double-blind Comparison of Pimozide (R-6238) with Chlorpromazine in Chronic Schizophrenia

A double-blind controlled study of therapeutic effects of pimozide were made in comparison with those of chlorpromazine.Subjects were 92 hospitalized schizophrenics, setting up in 46 pairs of the same sex, similar clinical conditions and with less than ten years disparity in age.One patient receiving chlorpromazine was dropped out after 4 weeks.After a one-week wash-out period, patients were first given daily 3 tablets (1 mg/tab.) of pimozide in a single dose or 6 tablets (25 mg/tab.) of chlorpromazine in three divided doses. The dose was then individualized depending on the symptoms in ratio of 1 tablet pimozide and 2 tablets chlorpromazine, within thelimits of 12 tablets or 24 tablets a day respectively.Global Comparative Judgement after 4 and 8 weeks' administration revealed no statistically significant difference between two drug groups in the sequential analysis. In General Improvement Rating after 8 weeks' administration, pimo zide caused improvement slightly better than chlorpromazine . Pimozide showed higher improvement rate than chlorpromazine after 8 weeks in items of “hal lucination”, “contact”, “working ability” and “care of clothing”.Incidence of side effects revealed no statistically significant difference between two except for salivation. Laboratory tests were also performed in all the subjects.