Statistical Significance In Favour Research Articles

Evaluation of unpreserved dexamethasone phosphate 0.1% versus placebo in patients with severe keratoconjunctivitis sicca (KCS) due to Sjögren's syndrome (SS)

Abstract Purpose KCS in SS is often associated with chronic inflammation. Moreover epithelial damage induces a release of local prostaglandins. Corticosteroids are potent inhibitors of many inflammatory pathways. Methods 21 patients were included in a double masked, intra‐individual comparison versus placebo, in patients with bilateral severe KCS due to SS. One drop of dexamethasone 0.1% was instilled in one eye tid during the first week of the study, bid during the following 2 weeks and qd during the last 2 weeks. One drop of placebo was instilled in the contra‐lateral eye with the same schedule. Patients attended 3 visits: D0, D7 and D35. A phone call was made on D70 to collect AEs and assess ocular discomfort. Symptomatology within the last 48h was evaluated on a VAS. Ocular symptoms and signs and safety were recorded at each visit. Results Both treatments resulted in a decrease of the patient’s ocular discomfort. At Day 35, a significant difference was found between the two treatments for the patient’s feeling of ocular discomfort, with better values under dexamethasone (p=0.007). No significant difference between treatments was observed on signs. But, the difference in Lissamine green total score between the 2 treatments almost reached statistical significance in favour of dexamethasone on D7 (p=0.056) and conjunctival hyperaemia improved faster with dexamethasone, as soon as D7. Investigators seemed to be more satisfied by the dexamethasone treatment both on Day 7 and Day 35. No statistically significant difference in overall tolerance assessments was observed between the two treatment groups. Conclusion Unpreserved dexamethasone 0.1% eye drops improve symptoms and signs due to KCS in SS.

The effect of escitalopram on sleep problems in depressed patients

The results from three 8-week escitalopram studies in major depressive disorder are presented with respect to efficacy and the effect on sleep quality, both in the full population and the subpopulation of patients with sleep problems at baseline. Analysis of pooled data from these randomized, double-blind, placebo-controlled, studies in which citalopram was the active reference, showed a significant improvement for escitalopram-treated patients (n = 52.0) in the Montgomery-Asberg depression rating scale (MADRS) item 4 ('reduced sleep') scores at weeks 6 and 8 compared with placebo (n=398; p < 0.01) and at weeks 4, 6 and 8 (n = 403; p < 0.05) compared with citalopram.Escitalopram-treated patients with sleep problems (MADRS item 4 score > or = 4; n = 254) at baseline showed a statistically significant improvement in mean MADRS item 4 scores at weeks 4, 6 and 8 compared with patients treated with placebo (n = 191; p < 0.05) or citalopram (n = 193; p < 0.01). These patients also showed a statistically significant (p < 0.05) and clinically relevant improvement in MADRS total score after escitalopram treatment compared with citalopram at weeks 1, 4, 6 and 8 (observed cases) and endpoint (-2.45; last observation carried forward [LOCF]). Statistical significance in favour of escitalopram versus placebo treatment was found at all visits, including endpoint (-4.2; LOCF).Thus, these post-hoc analyses suggest that escitalopram has a significant beneficial effect compared with placebo or citalopram in reducing sleep disturbance in patients suffering from major depressive disorder. The effect of escitalopram in improving 'reduced sleep' scores was clearly seen in patients with more severe sleep disturbance at baseline. A further prospective study is needed to establish this useful clinical effect in insomniac depressives.

Interventions for bullous pemphigoid.

Bullous pemphigoid is the most common autoimmune bullous disease in the West. Oral steroids are considered the standard treatment. To assess the effects of treatments for bullous pemphigoid. We searched the Skin Group Specialised Register, the Cochrane Central Register of Controlled Trials, MEDLINE, EMBASE to March 2003 and bibliographies from identified studies. Randomised controlled trials of treatments for patients with immunofluorescence confirmed bullous pemphigoid. Two reviewers evaluated the studies in terms of the inclusion criteria, five extracted data independently; disagreements were resolved by discussion. Statistical pooling of the data was inappropriate because of heterogeneity of treatments. We found seven randomised controlled trials with a total of 634 patients. All studies involved different comparisons, none included a placebo group. Different doses, different formulations of corticosteroids and the addition of azathioprine failed to show significant differences in measures of disease control. However, patients who took azathioprine were able to almost halve the amount of prednisone required for disease control. Plasma exchange plus prednisone achieved significantly better disease control than prednisone alone; this favourable effect was not apparent in another study. The latter study also compared plasma exchange or azathioprine plus prednisone, but failed to show significant differences for disease control or mortality, although total adverse events at six months almost reached statistical significance in favour of plasma exchange plus prednisone. Comparing tetracycline plus nicotinamide with prednisolone, no significant difference for disease response was shown. A very potent topical corticosteroid was compared to oral prednisone in patients with moderate and extensive disease. In patients with extensive disease, the topical steroid group showed significantly better survival and disease control, and less severe complications, while no significant differences for these outcomes were seen in patients with moderate disease. Most of the reported deaths were in patients taking high doses of oral corticosteroids. Very potent topical steroids are effective and safe treatments for bullous pemphigoid; their use in extensive disease may be limited by side effects and practical factors. Starting doses of prednisolone greater than 0.75 mg/kg/day do not seem to give additional benefit, lower doses may be adequate for disease control; this could reduce the incidence and severity of adverse reactions. The effectiveness of the addition of plasma exchange or azathioprine to corticosteroids has not been established. Combination treatment with tetracycline and nicotinamide may be useful; this needs further validation.

Double-blind, Placebo-controlled Cross-over Study of Intravenous S-Adenosyl-L-Methionine in Patients with Fibromyalgia

The objective of this study was to test the efficacy of intravenously administered S-adenosyl-L-methionine (SAMe) in patients with fibromyalgia (FM). Thirty-four out-patients with fibromyalgia symptoms Scand J Rheumatol SAMe 600mg i.v. or placebo daily for 10 days in a cross-over trial. There was no significant difference in improvement in the primary outcome: tender point change between the two treatment groups. There was a tendency towards statistical significance in favour of SAMe on subjective perception of pain at rest (p = 0.08), pain on movement (p = 0.11), and overall well-being (p = 0.17) and slight improvement only on fatigue, quality of sleep, morning stiffness, and on the Fibromyalgia Impact Questionnaire for pain. No effect could be observed on isokinetic muscle strength, Zerrsen self-assessment questionnaire, and the face scale. No effect of SAMe in patients with FM was found in this short term study.

Randomised Controlled Trial Comparing Endometrial Resection With Abdominal Hysterectomy for the Surgical Treatment of Menorrhagia

Objective To evaluate the effectiveness of endometrial resection as a surgical treatment for menorrhagia. Design Randomised controlled trial. Setting Gynaecology department at a teaching hospital. Subjects Two hundred women needing surgical treatment for menorrhagia between January 1990 and May 1991. After withdrawal of four women 97 underwent hysterectomy and 99 underwent endometrial resection. Main outcome measures Patient satisfaction 4 months after surgery; post-operative complications; length of hospital stay; duration of time before return to work, normal daily activities and sexual intercourse; change in premenstrual symptoms. Results The difference in patient satisfaction between endometrial resection (84 out of 99) and abdominal hysterectomy (89 out of 95) just reached statistical significance in favour of abdominal hysterectomy at 4 months after surgery (difference = 9%, 95% confidence intervals (CI) 1.1%–17.5%). Post-operative morbidity, length of hospital stay and time taken to return to work, normal daily activities and sexual intercourse were significantly less in the endometrial resection group. However, the premenstrual symptoms of dysmenorrhoea, bloating and breast tenderness were less frequent after hysterectomy. Conclusion In the short term, endometrial resection was almost as satisfactory as abdominal hysterectomy for the surgical treatment of menorrhagia, and was associated with less morbidity. However, even at 4 months after surgery, there was a failure rate of at least 10% in those in whom endometrial resection appeared complete. Longer term comparative studies are necessary before the widespread introduction of endometrial resection as an alternative to abdominal hysterectomy for the surgical treatment of menorrhagia.

Randomised controlled trial comparing endometrial resection with abdominal hysterectomy for the surgical treatment of menorrhagia

To evaluate the effectiveness of endometrial resection as a surgical treatment for menorrhagia. Randomised controlled trial. Gynaecology department at a teaching hospital. Two hundred women needing surgical treatment for menorrhagia between January 1990 and May 1991. After withdrawal of four women 97 underwent hysterectomy and 99 underwent endometrial resection. Patient satisfaction 4 months after surgery; post-operative complications; length of hospital stay; duration of time before return to work, normal daily activities and sexual intercourse; change in premenstrual symptoms. The difference in patient satisfaction between endometrial resection (84 out of 99) and abdominal hysterectomy (89 out of 95) just reached statistical significance in favour of abdominal hysterectomy at 4 months after surgery (difference = 9%, 95% confidence intervals (CI) 1.1%-17.5%). Post-operative morbidity, length of hospital stay and time taken to return to work, normal daily activities and sexual intercourse were significantly less in the endometrial resection group. However, the premenstrual symptoms of dysmenorrhoea, bloating and breast tenderness were less frequent after hysterectomy. In the short term, endometrial resection was almost as satisfactory as abdominal hysterectomy for the surgical treatment of menorrhagia, and was associated with less morbidity. However, even at 4 months after surgery, there was a failure rate of at least 10% in those in whom endometrial resection appeared complete. Longer term comparative studies are necessary before the widespread introduction of endometrial resection as an alternative to abdominal hysterectomy for the surgical treatment of menorrhagia.

A Double-Blind Endoscopic Study with De-Nol® Tablets and Cimetidine for Duodenal Ulcer

In a double-blind, double-dummy comparison of short-term ulcer healing, involving 50 patients treated with either De-Nol tablets (four times daily) or cimetidine tablets (400 mg, twice daily), no statistical difference in healing rates was observed after 8 weeks' treatment. There was, however, a numerical trend in favour of De-Nol (De-Nol, 100% healed; cimetidine, 88% healed). Statistical significance in favour of De-Nol was observed, however, in the reduction of antacid tablet consumption and relief of ulcer pain. No unwanted side effects were observed with either drug. This trial indicates that De-Nol and cimetidine are equally effective and useful in the short-term treatment of duodenal ulcer.