A prospective randomized trial of vagotomy in chronic duodenal ulceration.

In a prospective, randomized trial, 76 patients with duodenal ulceration treated by truncal vagotomy and pyloroplasty were compared with 77 patients who underwent highly selective vagotomy. A total of 149 patients was followed up for from 1 to 4 years, the average follow-up period being 2.6 years. There was no operative mortality and no significant difference in postoperative morbidity between the two groups. The incidence of recurrent ulceration was greater after highly selective vagotomy, but this difference was not statistically significant. The clinical results were comparable in each group, and although the incidence of diarrhoea and dumping was greater after vagotomy and pyloroplasty, this difference was not statistically significant.     

A comparative study of misoprostol and ranitidine in the healing of duodenal ulcers. A double-blind controlled trial

This study was undertaken to evaluate the safety and therapeutic efficacy of the prostaglandin E1 analogue, misoprostol, when compared with ranitidine in the healing of duodenal ulcers. Sixty patients with endoscopically proven duodenal ulcers participated in a double-blind controlled randomised trial comparing misoprostol 400 microgram and ranitidine 150 mg, both given twice daily orally for up to 8 weeks. Patient characteristics at entry into the trial were similar in the two treatment groups, except that there were 6 women in the ranitidine-treated group and none in the misoprostol-treated group. Ulcers were 0.3 - 2.0 cm in length. Healing was determined by endoscopy at 4 weeks; if ulcers were not healed, endoscopy was repeated at 8 weeks. All patients were given antacid tablets to be used as needed for pain up to a maximum of 8 tablets per day. Healing rates at 4 weeks for a total of 58 evaluate patients in the two treatment groups were: misoprostol (15/29; 51.7%) and ranitidine (20/29; 69.0%). Healing rates at 8 weeks for a total of 55 evaluable patients in the two treatment groups were: misoprostol (21/27; 77.8%) and ranitidine (24/28; 85.7%). The healing rate for misoprostol did not differ significantly from that for ranitidine at both the 4-week (P = 0.28) and the 8-week assessment (P = 0.68). Diarrhoea was the most common side-effect but was usually mild. It occurred in 11 patients on misoprostol and 1 patient on ranitidine. These results indicate that misoprostol 400 micrograms was taken twice daily orally for up to 8 weeks is effective and safe for the treatment of duodenal ulcer.     

Pirenzepine and cimetidine for duodenal ulcers. A comparative randomised double-blind controlled study

A double-blind controlled trial was undertaken to compare the relative effectiveness of pirenzepine (Gastrozepin; Boehringer Ingelheim) and cimetidine (Tagamet; SK & F) in healing endoscopically proven duodenal ulcers. Thirty patients with duodenal ulcers were treated with pirenzepine 50 mg twice daily and 30 patients with cimetidine 400 mg twice daily. Endoscopy was repeated after 4 weeks. Ulcers healed completely in 15 patients on pirenzepine and 21 patients on cimetidine (chi-square test 3.05; P less than 0.1); this difference was not significant. Treatment resulted in endoscopic improvement in 25 patients on pirenzepine and in 26 patients on cimetidine; this difference was also not statistically significant (chi-square test 1.18; P less than 0.5). No adverse effects were seen with cimetidine. Mild and reversible side-effects were seen in 4 patients on pirenzepine. The efficacy of pirenzepine appears similar to that of cimetidine in the healing of duodenal ulcers.     

Ranitidine in the treatment of gastric ulceration

Seventy-two patients with endoscopically proven gastric ulcers were entered into a prospective controlled trial to assess the efficacy of ranitidine and cimetidine in ulcer healing. All patients were biopsied on entry and at subsequent endoscopies. After exclusion of 7 patients during the first month of treatment, the remaining 65 patients, 47 males and 18 females, mean age 48.2 +/-1.5 years, at 1 month had a healing rate of 47% and 52% respectively. The non-healers continued their treatment for a further 4 weeks. This increased the healing rate to 77% and 76% respectively. If the defaulters and poor compliers are withdrawn the healing rate rises to 58% and 57% at 4 weeks and to 91% and 79% at 8 weeks respectively. There was no significant difference between the two groups as regarded initial ulcer size and severity of dyspepsia. Antacid tablet consumption during the study was comparable. The initial size of the ulcers which failed to heal after 4 weeks of treatment tended to be larger than those which healed (P less than 0.05), but smoking did not appear to influence ulcer healing. No obvious side-effects or evidence of dysplasia were found. The study shows that ranitidine is at least as effective as cimetidine in gastric ulcer healing.     

Bicitropeptide, antacid and placebo in gastric and duodenal ulceration. A two-centre, double-blind, comparative endoscopic study.

A bismuth-peptide complex (BCP Compound), an antacid (Maalox) and corresponding placebos were studied in a 6-week comparative double-blind trial of treatment in 106 randomized ambulant patients with endoscopically proven duodenal and gastric ulcers. Patients were examined after 1, 3 and 6 weeks' treatment and results assessed separately for duodenal and gastric ulcers on endoscopic evidence at weeks 3 and 6 respectively. Bicitropeptide was significantly better than antacid and placebo at 3 and 6 weeks for treatment of both duodenal and gastric ulcers. In the bicitropeptide group 100% of the patients in the duodenal ulcer group and 95,2% in the gastric ulcer group responded to treatment (improved or healed). No haematological or biochemical changes were noted and no adverse effects were recorded.     

Norfenefrine in the treatment of female stress incontinence. A double-blind controlled trial

Forty-four consecutive patients with genuine stress incontinence were treated with norfenefrine 15-30 mg t.i.d. in a 6-week, double-blind and parallel, placebo-controlled study. Subjectively, 52% were improved and 26% became continent during norfenefrine treatment. Objectively (stress test), 30% became continent and the maximum urethral closure pressure increased 10% which was statistically significant. These results, however, were not statistically different from those of placebo treatment. Simultaneously, subjective and objective improvement was seen more often in patients given norfenefrine compared to placebo (p less than 0.1). In patients with most severe incontinence according to urodynamic criteria the effect of norfenefrine was statistically significantly better than placebo. A low incidence of side effects was observed and no differences between norfenefrine and placebo were found. It is concluded that norfenefrine may be of value in the treatment of female stress incontinence.     

A prospective randomized trial of vagotomy in chronic duodenal ulceration: 4-year follow-up

A total of 153 patients (124 male and 29 female) with uncomplicated chronic duodenal ulceration were studied in a prospective, randomized trial of proximal gastric vagotomy (PGV) and truncal vagotomy and pyloroplasty (TVP), conducted in four Manchester hospitals. Of these, 137 patients have now been followed up for 2.5 to 5.5 (mean 4.1) yr. There have been 15 (21 per cent) recurrent ulcers following PGV compared with 5 (7.5 per cent) after TVP (P less than 0.05). A satisfactory functional result was obtained in 82 per cent of patients after TVP compared with 73 per cent following PGV and there was little difference between the groups with regard to the incidence of dumping, heartburn and vomiting. There was significantly more diarrhoea following TVP (13 per cent) compared to PGV (1.4 per cent) but this represented only a minor clinical problem.     

A double-blind randomized controlled trial of toremifen therapy for mastalgia

HYPOTHESIS: Toremifen is effective in reducing breast pain and does not increase the incidence of adverse events as a therapy for moderate to severe mastalgia.Design and PATIENTS: In a double-blind randomized controlled trial, patients with moderate to severe mastalgia received toremifen citrate, 30 mg daily, or a placebo tablet for 3 menstrual cycles and were followed up for breast pain score and adverse events. The serum levels of estradiol, progesterone, and prolactin were examined before treatment and correlated with the response rate to toremifen treatment. RESULTS: Seventy-two (69.2%) of 104 patients receiving toremifen and 29 (31.9%) of 91 receiving placebo responded to the treatment, with reduction in breast pain score of more than 50% (P<.001). Among the patients with cyclical mastalgia, the response rate for toremifen was 76.7% (59/77), whereas the response rate for placebo was 34.8% (23/66; P<.001). In contrast, the response rate of patients with noncyclical mastalgia was 48.1% (13/27) for toremifen and 24.0% (6/25) for placebo (P = .09). Adverse events were observed in 44 (42.9%) of 104 patients receiving placebo and 46 (50.5%) of 91 patients receiving toremifen (P = .45). A positive correlation between baseline breast pain score and serum estradiol level was observed in patients with cyclical mastalgia (r = 0.35, P = .003). CONCLUSIONS: Toremifen effectively relieves moderate and severe cyclical mastalgia and tends to exert a positive therapeutic effect on noncyclical mastalgia. In addition, toremifen therapy does not increase the incidence of intolerable adverse event. Therefore, it is a feasible therapy for mastalgia, especially cyclical mastalgia.     

Choledochopancreatoduodenal fistula caused by duodenal ulceration. A case report

A penetrating duodenal ulcer may occasionally erode into the common bile duct and form a choledochoduodenal fistula. Such a fistula occurring simultaneously with a pancreatic duodenal fistula is reported. The presenting features of these fistulas are those of the ulcer and confirmation of the fistula may be difficult, although use of endoscopic retrograde cholangiopancreatography has greatly facilitated their diagnosis. In this case both fistulas could be cannulated through the base of the ulcer. The majority of these fistulas heal spontaneously with intensive medical management. The remainder require surgery, and a conservative approach avoiding direct interference with the fistula should be adopted. Drainage procedures are rarely required and once closed the fistulas usually cause no further problem.     

A randomized controlled double-blind trial comparing piritramide and morphine for analgesia after hysterectomy.

BACKGROUND AND OBJECTIVE: Efficacy and side-effects of piritramide (pirinitramide) and morphine, given intravenously for postoperative analgesia after hysterectomy, were compared in a randomized controlled double-blind trial in 92 ASA class I-III patients. METHODS: Administration was investigator-controlled during the first 90 min and subsequently via a patient-controlled device. Visual analogue scales for pain intensity and verbal rating scales for side-effects were taken repeatedly. RESULTS: Median visual analogue scores for pain intensity on a 100-mm scale 4, 8 and 24 h after surgery were 10, 8.5 and 5 mm in the piritramide group and 18, 10 and 8.5 mm in the morphine group. These differences are neither statistically nor clinically significant. Median values for nausea on a verbal rating scale from 0 to 3 were zero for both groups at all times with similar ranges. There was no difference in number of episodes of vomiting and retching and usage of antiemetics. The mean amount of piritramide used for initial titration was 15.2 mg; the respective amount of morphine was 15.4 mg. CONCLUSIONS: In this setting the two agents are equally effective and show a similar profile of side-effects.     

Randomized trial of elective highly selective or truncal vagotomy in chronic duodenal ulceration

Between 1973 and 1976, 153 patients (124 men, 29 women) with uncomplicated, chronic, duodenal ulcer were entered into a prospective randomized trial of highly selective vagotomy (HSV) or truncal vagotomy and pyloroplasty (TVP). The study was conducted in four Manchester hospitals and the operations were performed by consultants or chief registrars. The follow-up was conducted by personal interview using a standardized questionnaire. The medical gastroenterologist did not know which type of operation the patient had had. The patients who had symptoms were referred back to the surgeon who performed the operation. The clinical laboratory and follow-up data were analysed by computer. There were no operative deaths. Three patients died from unrelated causes, 13 were lost to follow-up; 137 (89.5%) were followed up for a mean of 4.1 years (range from 2.5 to 5.5 years). A modified Visick grading was used to assess the results of surgery. The outcome was good in 82% after TVP and 73% after HSV. This difference and those in the incidences of early or late postprandial dumping, bilious vomiting, weight loss, anemia and heartburn were not significant. Diarrhea was more frequent after TVP (13.4%) than after HSV (1.4%); although the difference was significant (p less than 0.025), this complaint did not present a serious clinical problem. Ulcers recurred in 15 (21.4%) patients following HSV and in 5 (7.5%) after TVP; this difference was statistically significant (p less than 0.05).     

Ureteral catheterization in uncomplicated ureterolithotripsy: a randomized, controlled trial

OBJECTIVE: To evaluate short-term ureteral catheterization in patients undergoing ureteroscopic lithotripsy for ureteral calculi. METHODS: Patients (n = 140) with ureteral calculi who were candidates for ureterolithotripsy were enrolled. Stone size was 5-10mm. The operation was performed with an 8-9.8F semirigid ureteroscope without active dilatation and stones were fragmented with a 1F pneumatic lithotrite. Uncomplicated cases (109 patients) were randomized to catheterized (C) and noncatheterized (NC) groups. In the 54 C group patients, a polyurethane catheter (5F) was passed through the ureter after lithotripsy with the end attached to a Foley placed in urethra, which was removed after 24h. Postoperatively, all patients were evaluated for flank and suprapubic pain, renal colic, irritative urinary symptoms, peritonism, frequency of analgesic usage, urinary tract infection, duration of hospitalization, postdischarge visits (due to renal colic/pain), readmission, and residual stone rates. RESULTS: On the first postoperative day, the percentage of patients experiencing flank pain and renal colic was significantly higher in the NC group (76% and 45%) compared with the C group (20% and 2%); 67% of NC patients required analgesic administration during hospital stay versus 20% of C patients (p<0.001). Suprapubic pain and urethral irritation were reported by 13% and 37% of C patients, respectively, and 5% and 4% of NC patients. However, peritonism was developed more often in NC patients (27% vs. 13%). Hospital stay was 1 d for all patients. Three days postoperatively, 40% of NC patients complained of at least one episode of flank pain compared with 7% of C patients (p<0.001). Incidence of urinary tract infections was 4% in NC and 7% in C group patients. Postdischarge visits were necessary in 20% of NC patients and 5% of C patients. No patient in either group required readmission. No complaints were reported nor residual stones discovered on 2-wk follow-up radiographs in either group. CONCLUSIONS: Short-term ureteral catheterization in uncomplicated ureteroscopy and lithotripsy has a role in reducing early postoperative morbidities. It may also decrease pain and colic after discharge.     

A double-blind randomized controlled trial of isoflavones in the treatment of cyclical mastalgia

Cyclical mastalgia is very common in Western populations and is believed to have an hormonal basis. Simple measures such as vitamins or evening primrose oil are not very effective, yet the disease rarely warrants anti-oestrogen therapies. Isoflavones are a subgroup of phytoestrogens which we hypothesized might be a simple and effective means of therapy as they act as a weak anti-oestrogen in pre-menopausal women and have no side-effects. A double-blind randomized control trial of either placebo, 40 mg or 80 mg of isoflavones was undertaken after an initial 2 month single-blind 'Placebo Lead-in' to exclude women with a significant placebo response. Eighteen women were randomized to the treatment phase of the trial. Nine of the 12 women on treatment had a worthwhile improvement in their pain compared to only two of six on placebo. The reduction in pain was 13% for placebo, 44% for 40 mg of isoflavone per day and 31% for 80 mg per day. There have been no previous clinical studies of isoflavones for the treatment of mastalgia and the benefit demonstrated in this study adds another valuable arm to therapy.     

Second-stage duodenal switch for sleeve gastrectomy failure: A matched controlled trial

Background

Sleeve gastrectomy (SG) has become the predominant bariatric surgery worldwide. However, the surgical management in case of failure is still debated.

A prospective controlled double-blind trial of great auricular nerve preservation at parotidectomy

BACKGROUND: Earlier reports of the advantages of preservating the posterior branches of the great auricular nerve (GAN) at parotidectomy were conflicting. This prospective study was aimed at clarifying the controversy. METHODS: Eighty-one patients in a university otolaryngology department were recruited. The posterior branches were preserved whenever initial dissection showed that tumor clearance would not be compromised. Touch-pressure sensation was monitored in predefined territories supplied by the GAN using a Semmes-Weinstein aesthesiometer, preoperatively and postoperatively. Minimal pressure thresholds obtained were compared between the two groups. RESULTS: Preservation of the GAN was achievable in 69% of patients; sensory deficit was transient. With the GAN divided, measurable sensory depression occurred up to 2 years after surgery. The difference is statistically significant. Patients' subjective assessment of numbness also conformed to these trends. Additional time taken for preservation of the GAN was about 10 minutes. CONCLUSIONS: The posterior branches should always be preserved if tumor clearance is not compromised.