Comparison of various treatments for irritable bowel syndrome.

A previous therapeutic trial of factorial design showed that a combination of a psychotropic drug, a smooth-muscle relaxant, and a bulk former (lorazepam, hyoscine hydrobromide, and ispaghula husk) relieved symptoms of the irritable bowel syndrome more effectively than the same agents given singly. Another trial of similar design was undertaken to compare each of these three agents with another having the equivalent clinical actions--namely, Motival (fluphenazine/nortriptylene mixture), mebeverine, and bran. Ninety-six patients took part; all received three agents, one from each of the three pairs being compared, and no placebos were used. Fifty-six patients reported a sustained symptomatic improvement, which was a significantly higher incidence than in the previous trial, when placebos were used. Ispaghula was significantly more effective than bran. The combination of ispaghula, Motival, and mebeverine improved 11 out of 12 patients--significantly more than bran, Motival, and hyoscine (five improved), or bran, lorazepam, and mebeverine (four improved). Mebeverine was significantly more effective when combined with Motival (18 out of 24 improved) than with lorazepam (10 improved). These results confirm the value of a combined therapeutic approach to the relief of the irritable bowel syndrome and suggest the possibility of synergism between agents.     

Healing of gastric ulcers after one,two, and three months of ranitidine.

Ranitidine (150 mg twice daily) was compared with placebo in 42 patients with gastric ulcer. The study was conducted as a double-blind trial for one month, followed by an open assessment of one, two, and three months of ranitidine in the patients with persistent ulceration. Thirty-eight patients completed the double-blind trial. Repeat endoscopy confirmed complete healing in 16 of the 21 who had received ranitidine and five of the 17 who had received placebo (p less than 0.01). The remaining 17 patients with persistent ulceration participated in the open assessment. The combined cumulative healing rates of ranitidine at four, eight, and 12 weeks were 73%, 88%, and 97%. There were no adverse effects or unusual reasons for withdrawal from the study (four patients). Ranitidine appears to be a safe and highly effective treatment of gastric ulceration, with about 90% of ulcers healed after eight weeks.     

阿泰宁治疗肠易激综合征50例的疗效观察

目的 观察和评价阿泰宁（含酪酸梭菌CGMCC NO.0313-1株）治疗肠易激综合征（IBS）的临床疗效.方法 对符合罗马Ⅱ诊断标准的IBS患者,用阿泰宁胶囊口服,1次3粒,1天2次,疗程14～21 d.治疗期间观察患者的症状变化、服药情况,治疗结束后评价药物的疗效.结果 50例IBS患者治疗后的腹泻或便秘等症状有显著的改善（P＜0.05）.治愈率为62%（31/50）,总有效率为94%（47/50）,治疗中未见不良反应或副作用.结论 阿泰宁是治疗IBS的一种安全有效的微生态药品,不但短期应用效果好,而且慢性腹泻或便秘患者可长期服用.     

Electroconvulsive therapy: results in depressive illness from the Leicestershire trial.

Electroconvulsive therapy was investigated in a double blind trial. Altogether 186 clinically selected patients were referred to the trial, but 48 of these did not participate. According to the present state examination, 95 of the remaining 138 patients fell into one of the classes of major depression. Patients were randomly allocated to a course of real or simulated electroconvulsive therapy. Treatment was given twice a week with a maximum of eight treatments. On the Hamilton depressive rating scale the improvement in the group given real treatment was significantly greater than that in the group given simulated treatment both at two weeks (p = 0.014) and at four weeks (p = 0.0001). At follow up at 12 and 28 weeks there was no difference between the treatment groups. At the end of the four week trial consultants, who were blind to the allocation of treatment, rated the patients who had received real treatment as having made a significantly greater improvement than the patients who had received simulated treatment (p less than 0.00005). Further analysis showed that electroconvulsive therapy was effective in depression associated with delusions and in depression associated with retardation.     

凝结芽胞杆菌(TBC169)片治疗便秘的实验研究和临床疗效

目的观察凝结芽胞杆菌片（BC1）对便秘的药理作用和I临床疗效。方法昆明种雄性小鼠随机分为6组（每组10只）。BC1片（3个剂量）和BCz片治疗组小鼠口服BC。片和BC2片,空白对照组小鼠和模型对照组小鼠口服自来水,每天1次,共7d。之后,两治疗组和模型对照组小鼠在禁食12h后．均口服复方地芬诺酯（CDX）片,引发便秘。成人慢性便秘38例患者随机分为治疗组（20例）和对照组（18例）,分别口服BC1片和金双歧片（BG）,每天3次,共14～21d。结果BC1片能明显地减少便秘小鼠的首次排便时间（P〈0．05）和显著地增加大便粒数及重量（P〈0．05）。在临床试验中,治疗成人慢性便秘,BC1片的治愈率为45％,总有效率为70％,而相对的BG片分别为44％和72％,两药均未见不良反应或副作用。结论BC1片对小鼠实验性便秘和成人慢性便秘均有明显的治疗作用,在临床试验中未见不良反应或副作用。     

Results of the treatment of Wilson's disease with zinc sulfate and d-penicillamine]

Nine patients with newly diagnosed Wilson's disease were treated with zinc sulphate for 12 months. Polish preparation Zincteral was administered in doses of 200 mg 4 times daily. The neurological status has improved in five cases. No adverse reactions of zinc sulphate were observed. The results were compared with the therapeutic effect, obtained in the group of 10 patients who received d-penicillamine (Cuprenil-Polfa) 1.0-1.5 g daily from the very beginning. In three cases drug was discontinued due to adverse reactions. In remaining seven cases, in five evidence of the clinical improvement of the neurological status was observed, but in one case during 12 months of observation progressing deterioration was noticed. Neurological state of one patient remained unchanged.     

Cell therapy with autologous mesenchymal stromal cells in post-traumatic syringomyelia

Background aims

Recently, clinical studies show that cell therapy with mesenchymal stromal cells (MSCs) improves the sequelae chronically established in paraplegic patients, being necessary to know which of them can obtain better benefit.

Azathioprine in Ulcerative Colitis: An Interim Report on a Controlled Therapeutic Trial

This interim report on a controlled therapeutic trial of azathioprine in ulcerative colitis deals with the first 40 patients to complete a one-year period of maintenance treatment with azathioprine or with dummy tablets. The patients all suffered from classical ulcerative colitis and were in an actual attack of the disease at the time of admission. The attack was treated with a standard corticosteroid regimen and the patients were assigned at random to maintenance treatment with real or dummy azathioprine tablets, using a stratified design. The treatment and control groups were closely similar at the beginning of the trial.The effect of treatment has been assessed on the basis of the number of relapses of the disease occurring during the one-year trial period, supplemented by an assessment of the sigmoidoscopic picture and of the histological findings on serial rectal biopsy. In the patients receiving azathioprine the disease ran a more favourable course than in the control group. After the attack had been treated 11 of the 20 patients on azathioprine were symptom-free throughout the rest of the one-year trial period compared with only 5 out of 20 in the control group. The only three patients classed as failures were all in the control group. These differences just fail to reach conventional levels of statistical significance.Azathioprine is not dramatically successful but may still be a useful addition to the medical treatment of ulcerative colitis, particularly if conventional medical treatment is ineffective and there are reasons for wishing to avoid radical surgery. In the dose used azathioprine was virtually free from undesirable side effects.     

Comparison between a slow-release oral preparation of bromocriptine and regular bromocriptine in patients with hyperprolactinemia: a double blind, double dummy study.

The efficacy and tolerability of a slow-release preparation of bromocriptine (Parlodel SRO) were compared to those of conventional bromocriptine (Parlodel R) in a double blind, double dummy study of 12 hyperprolactinemic women (plasma PRL 81.3 +/- 4.73, ng/ml mean +/- SEM). For 2 weeks, the patients received 2.5 mg b.i.d. Parlodel R or 5 mg once daily Parlodel SRO; for the following 2 weeks, the dose of the drugs was doubled. The patients were then treated, in an open study, with 2.5-10 mg daily Parlodel SRO for 6 months. Both preparations caused a prompt and sharp PRL fall. Hormone levels remained inhibited over the whole month of observation with both preparations. Daily PRL profiles were very close with either drug although morning PRl levels were slightly higher during Parlodel SRO than during Parlodel R administration. Doubling the doses of the two drugs did not result in further significant lowering of PRL values. During the 6-month study with Parlodel SRO, plasma PRL further decreased and normalized in 11 of 12 patients. Clinical improvement occurred in the majority of cases. Tolerability of Parlodel SRO appeared to be better, though without statistically significant differences, than that of Parlodel R. Side effects were less important with the former compound in their number, severity and duration. In conclusion, thanks to its favourable pharmacological profile, Parlodel SRO appears to be a valuable alternative to regular bromocriptine in the management of hyperprolactinemia.     

Endpoints,patient selection,and biomarkers in the design of clinical trials for cancer vaccines

Therapeutic cancer vaccines are an emerging and potentially effective treatment modality. Cancer vaccines are usually very well tolerated, with minimal toxicity compared with chemotherapy. Unlike conventional cytotoxic therapies, immunotherapy does not result in immediate tumor shrinkage but may alter growth rate and thus prolong survival. Multiple randomized controlled trials of various immunotherapeutic agents have shown a delayed separation in Kaplan–Meier survival curves, with no evidence of clinical benefit within the first 6–12 months of vaccine treatment. Overall survival benefit is seen in patients with lower disease burden who are not expected to die within those initial 6–12 months. The concept of improved overall survival without marked initial tumor reduction represents a significant shift from the current paradigms established by standard cytotoxic therapies. Future clinical studies of therapeutic vaccines should enroll patients with either lower tumor burden, more indolent disease or both, and must seek to identify early markers of clinical benefit that may correlate with survival. Until then, improved overall survival is the only clear, discriminatory endpoint for therapeutic vaccines as monotherapies.     

Cellulite treatment: a myth or reality: a prospective randomized, controlled trial of two therapies, endermologie and aminophylline cream

Cellulite is a common phenomenon that particularly affects the thighs and buttocks of women. Little scientific evidence exists to support any of the many advertised treatments for it. A total of 52 of 69 women, who were divided into three groups, completed a 12-week, randomized, controlled trial in which the effectiveness of two different treatments for cellulite was assessed. The patients acted as their own controls. The treatments investigated were twice-daily application of aminophylline cream and twice-weekly treatment with Endermologie ES1. Group 1 (double blind) received aminophylline to one thigh/buttock and a placebo cream to the other. Group 2 (singly blind) received Endermologie to one thigh/buttock. Group 3 received Endermologie to both sides and used the same cream regimen as group 1. Results were assessed subjectively by the patient and by clinical examination and photographic assessment by the surgeon (before and after the trial). Morphologic assessment included body mass index, thigh girth at two points, and thigh fat depth measurement by ultrasound. No statistical difference existed in measurements between legs for any of the treatment groups (paired t test, p > 0.4). The best subjective assessment, by the patients themselves, revealed that only 3 of 35 aminophylline-treated legs and 10 of 35 Endermologie-treated legs had their cellulite appearance improved. The authors do not believe that either of these two treatments is effective in improving the appearance of cellulite.     

L-Dopa in Parkinsonism and the Influence of Previous Thalamotomy

A double-blind cross-over trial over 24 weeks (10 weeks on the active remedy, 4 weeks off treatment, and 10 weeks on placebo) of the effect of L-dopa on idiopathic Parkinsonism (paralysis agitans) has shown no difference in the response obtained in patients who had undergone previous stereotaxic ventrolateral thalamotomy and in those who had not. Of the 34 patients (18 men and 16 women) in the trial 18 had been operated on (nine unilateral, nine bilateral operations) and 16 had not. All patients entering the trial were taking anticholinergic drugs in stable dosage and these were continued throughout. The only factor which seemed to limit the response to treatment was pre-existing hypertension. Of 31 patients who completed the 10-week treatment period, 12 showed marked improvement, 15 moderate improvement, and 4 and mild or negligible change. It seems that previous ventrolateral thalamotomy affords some protection against the development of L-dopa-induced involuntary limb movements on the side contralateral to the operation. As found by others, maximum benefit was seen in bradykinesia and rigidity and related features but a significant reduction in tremor was also noted during treatment. Side effects (nausea, hypotension, and involuntary movements) were common but rarely limited the therapeutic response.     

Chronic Granulocytic Leukaemia: Multiple-drug Chemotherapy for Acute Transformation

The response to 60 trials of therapy in 50 patients with chronic granulocytic leukaemia (C.G.L.) in acute transformation is reported. None of the 13 patients who received single-agent chemotherapy had a satisfactory response. The use of two drugs in combination produced only one satisfactory response in 30 patients. Various types of multiple-drug treatments in eight patients achieved one good response which lasted four months. In contrast when nine patients with rapidly progressive acute transformation of C.G.L. received a regimen—TRAMPCO(L)—incorporating seven or eight drugs (thioguanine, daunorubicin, cytarabine, methotrexate, prednisolone, cyclophosphamide, and vincristine, with or without L-asparaginase colaspase) five improved significantly. Four patients had a good clinical and haematological response with survival for over three, eight, over 12, and 14 and a half months; and one patient had a partial response. Toxicity was not extreme and maintenance therapy with the same regimen was given on an outpatient basis. TRAMPCO(L) seems superior to previously reported regimens and should be considered for rapidly progressive transformation of C.G.L. especially when simpler treatments have failed.     

THIORIDAZINE (MELLARIL?) IN PSYCHIATRIC PATIENTS

Thioridazine (Mellaril®) was given to 104 psychiatric patients with a variety of illnesses, chiefly schizophrenic reactions. Of 14 patients treated in a double-blind study with successive one-month courses of drug or placebo, nine improved most on the drug and only one on placebo. These results, although limited, confirm a definite therapeutic action for this compound.Nine of 24 patients were significantly improved after treatment with thioridazine for an average of four months following previous treatwith other phenothiazine tranquilizers. Of ten patients treated intensively with thioridazine after they had not responded to other phenothiazine drugs, two were definitely improved and three were slightly improved. Twenty-eight of 56 patients treated from the outset with thioridazine were significantly improved after an average of six months. Most patients received from 100 to 400 mg. daily. These results were comparable to those obtained from other potent phenothiazine tranquilizers. The drug is particularly advantageous for a group of schizophrenic patients who are sometimes made worse by other phenothiazine derivatives or rauwolfia alkaloids. It should also be suitable for treating patients with psychoneuroses and chronic brain syndromes.Only minimal side reactions were observed, chiefly drowsiness, dizziness and nasal stuffiness. Weight gain occurred frequently during treatment.     

Behavioral treatment of irritable bowel syndrome: a 1-year follow-up study

Sixteen clients afflicted with irritable bowel syndrome (IBS) were reassessed 1 year following completion of a multicomponent treatment package incorporating progressive muscle relaxation, thermal biofeedback, cognitive therapy, and IBS education. For the 14 patients who kept a 2-week symptom diary, significant reductions in ratings of abdominal pain and tenderness, diarrhea, and flatulence were obtained comparing pretreatment and follow-up symptom-diary ratings. Eleven of 14 clients were improved over pretreatment levels, 57% met the criteria for clinical improvement of at least a 50% reduction in major symptom scores, and all but 1 of 16 rated themselves as subjectively improved.     

Behavioral treatment of irritable bowel syndrome: A 1-year follow-up study

Sixteen clients afflicted with irritable bowel syndrome (IBS) were reassessed 1 year following completion of a multicomponent treatment package incorporating progressive muscle relaxation, thermal biofeedback, cognitive therapy, and IBS education. For the 14 patients who kept a 2-week symptom diary, significant reductions in ratings of abdominal pain and tenderness, diarrhea, and flatulence were obtained comparing pretreatment and follow-up symptom-diary ratings. Eleven of 14 clients were improved over pretreatment levels, 57% met the criteria for clinical improvement of at least a 50% reduction in major symptom scores, and all but 1 of 16 rated themselves as subjectively improved.     

Long-term treatment of severe hypertension with minoxidil.

Minoxidil, a new potent hypotensive agent, was used as the primary antihypertensive agent in 11 patients--10 men and 1 woman aged 35 to 54 years with severe hypertension that was refractory to treatment with maximal (or maximally tolerated) doses of conventional antihypertensive agents. Six patients had severely impaired renal function and three of them were undergoing long-term hemodialysis. The patients were given 2.5 to 40 mg/d of minoxidil for periods of 2 to 29 months. All except one who was almost anuric received propranolol and diuretics. Blood pressure was controlled satisfactorily in all patients. In two patients the hypertension became partially resistant after 1 year of treatment. The main side effects were sodium retention, tachycardia and hirsutism. Renal function remained stable or improved and hemodialysis was discontinued in two patients. Minoxidil is a remarkably potent hypotensive with relatively few side effects and seems particularly advantageous in patients with chronic renal failure.     

The coincidence of TRAM flaps and prostheses in the setting of breast reconstruction

It is well known that transverse rectus abdominis myocutaneous (TRAM) flaps can be used to replace unsatisfactory prosthetic breast reconstructions; however, little has been written about the scope of breast implant use in TRAM flap patients. In this study, to ascertain the range of such therapeutic options, their frequency, and their clinical outcomes, the authors retrospectively reviewed the senior author's breast reconstruction experience from 1989 to 2000 with patients in whom both a TRAM flap and an implant were used for breast reconstruction. The authors examined the surgical indications, body habitus, bra size, chest wall irradiation history, flap type, implant type, complications, and outcomes for those patients with TRAM flap and breast implant combinations.Thirty-two women who had 50 (various) combinations of a TRAM flap and a breast implant were identified. There were more clinical scenarios than patients because many of the women had multiple scenarios. The 50 combination scenarios were then divided into six groups. Group I consisted of 14 patients who had elective prostheses placed beneath simultaneous TRAM flaps; group II consisted of 10 patients who had TRAM flaps with contralateral prosthetic reconstruction (in which two implants were received before the TRAM flaps, five implants were received simultaneously with the TRAM flaps, and three implants were received after the TRAM flaps); group III consisted of eight patients who had contralateral augmentation in addition to their TRAM flaps; group IV consisted of 11 patients who had TRAM flaps that were used to cover or replace previous prosthetic reconstructions; group V consisted of four patients in whom prostheses were used to augment or improve previous TRAM flap reconstructions; and group VI consisted of three patients who required prostheses to either reconstruct or salvage total or near-total TRAM flap failures. A broad range of implant types was used, although anatomic saline implants predominated. Forty-one percent of the patients in the review had undergone irradiation during the course of their treatment for breast cancer. Eight of the 32 patients experienced a total of twelve complications, four of which were related to the implants and eight of which involved the TRAM flaps and abdominal donor sites.Although complex, the wide variety of potential TRAM flap/breast implant combinations can be useful for patients with challenging reconstructive scenarios, particularly those that involve radiation therapy. In the group of patients reviewed by the authors, TRAM flaps were most often used in successful partnership either on the same side as or opposite to an implant reconstruction. A TRAM flap was used to salvage or replace an unsatisfactory implant reconstruction in less than a third of the patients. From a risk point of view, implants used opposite a TRAM flap reconstruction had a lower incidence of complication than did implants used beneath TRAM flaps.     

Relaxation training as a treatment for irritable bowel syndrome

Although there have been many successful, controlled demonstrations of the clinical efficacy of multicomponent treatments for irritable bowel syndrome (IBS), in the present study we sought to evaluate a single component of many of these regimens, relaxation training. Eight IBS patients received a 10-session (over 8 weeks) regimen of abbreviated progressive muscle relaxation with regular home practice while 8 comparable patients merely monitored GI symptoms. Based on daily GI symptom diaries collected for 4 weeks before and 4 weeks after treatment (or continued symptom monitoring), the Relaxation condition showed significantly (p=.05) more improvement on a composite measure of primary GI symptom reduction than the Symptom Monitoring condition. Fifty percent of the Relaxation group were clinically improved at the end of treatment.