Placebo In Treatment Of Patients Research Articles

Placebo in functional dyspepsia: symptomatic, gastrointestinal motor, and gastric sensorial responses.

Therapeutic trials in functional dyspepsia consistently show a substantial placebo response, but there is no clear explanation for such an effect. Our aim was to evaluate symptomatic, gastrointestinal motor, and gastric sensorial responses to placebo treatment in patients with chronic and severe functional dyspepsia who were part of a therapeutic trial. Thirty patients were treated during 8 wk with placebo (white-colored 8-mm tablets containing cellulose) by mouth, 20 min before breakfast, lunch, and dinner. We quantified the symptomatic response to placebo as a change in global health status, and also as a change in the individual and combined (global symptom index) of a five-symptom complex: upper abdominal pain, nausea, vomiting, bloating/fullness, and early satiety. Gastroduodenal motility, during fasting and postprandially, was evaluated by manometry in all patients pretreatment and in 17 patients posttreatment. Gastric sensitivity to distension was evaluated in 18 patients pretreatment and in five patients posttreatment (all of them clinical responders). Placebo treatment produced a striking symptomatic improvement; by 8 wk 80% of the patients reported an improved global health status and their global symptom index markedly decreased (23.9+/-1.3 pretreatment vs 9.1+/-1.2; p < 0.05). Placebo increased the number of gastric phases III starting in the antrum during the fasting period (1.1+/-0.1 vs 1.6+/-0.2; p < 0.05). As a group, no significant changes in postprandial gastroduodenal motility were observed after placebo treatment. However, after placebo a significant improvement in the antral motility index (MI) was observed in the subset of patients with antral hypomotility (MI pretreatment: 7.9+/-1.0; MI posttreatment: 11.7+/-0.4; p < 0.05). Before placebo treatment, patients with functional dyspepsia showed increased sensitivity to stepwise distension of the stomach relative to healthy individuals. After 8 wk of placebo treatment sensitivity to distension remained unchanged, even though patients' clinical status was markedly improved. In patients with functional dyspepsia, the symptomatic response to placebo is substantial. Some significant changes were also observed in gastric motility: increase in the gastric phase III number as well as in the postprandial antral motility index in those with hypomotility pretreatment. Remarkably, however, clinical improvement seems to occur independently of detectable changes in gastroduodenal motor activity or gastric hypersensitivity to distension.

Clinical adverse events observed during oral placebo treatment in patients with functional gastrointestinal disorders

Clinical adverse events observed during oral placebo treatment in patients with functional gastrointestinal disorders

Effectiveness of Ketorolac Tromethamine 0.5% Ophthalmic Solution for Chronic Aphakic and Pseudophakic Cystoid Macular Edema

The effect of ketorolac tromethamine 0.5% ophthalmic solution (a new nonsteroidal anti-inflammatory agent) treatment was compared to placebo treatment in patients with chronic, angiographically proven aphakic or pseudophakic cystoid macular edema (visual acuity less than or equal to 20/40 for six months) during a three- to four-month double-masked, randomized study. Twenty-six patients completed this study without significant ocular or systemic toxicity. The improved distance visual acuity observed in the ketorolac treatment group (8/13 patients) was statistically different from the improved vision observed in the placebo treated group (1/13 patients) (P = .005). No patient on a regimen of ketorolac therapy had a significant decrease in Snellen distance visual acuity while on treatment, but two patients in the placebo group demonstrated a decrease in visual acuity of two lines or more. Fluorescein angiography was consistent with changes in visual acuity.

Controlled trial of thyrotropin releasing hormone tartrate in ataxia of spinocerebellar degenerations

The clinical efficacy, dose-response relationship, and safety of TRH-T (thyrotropin releasing hormone tartrate) were assessed in 290 patients with spinocerebellar degeneration (SCD) in a 2-week, double-blind study using placebo as control. 254 patients satisfied the criteria for inclusion in evaluation of the drug efficacy. The patients were treated with TRH-T in an intramuscular dose of 2 mg, 0.5 mg or 0 mg (placebo) as TRH once a day for 2 weeks. Clinical responses to these treatments were evaluated 3 times: at the end of weeks 1 and 2 of treatment and a week after the end of treatment. The results of “global improvement rating” as well as those of “ataxia improvement rating” showed that both 2 mg and 0.5 mg TRH-T treatments were significantly superior to placebo treatment in patients with predominantly cerebellar form of SCD. The effect was well maintained a week after the end of the 2-week treatment in the patients who were given TRH-T in daily dose of 2 mg and showed improvement at the end of treatment. The results of “improvement rating of each symptom” revealed that 2 mg treatment was significantly more effective than placebo for disorders of standing, gait, speech and writing. In the patients who had no pyramidal involvement or disorder of deep sensation, the drug efficacy and dose-response relationship were evident. Adverse reactions to the drug such as headache, feeling febrile and nausea were observed in 50% of the patients on 2 mg treatment, in 38% of those on 0.5 mg treatment and in 21% of those on placebo patient, however, discontinued treatment because of adverse reactions. The results suggest that TRH-T improves ataxia in patients with SCD, especially of predominantly cerebellar form.

Safety and Efficacy of Chymopapain (Chymodiactin) in Herniated Nucleus Pulposus With Sciatica

A double-blind, randomized trial was conducted to compare the efficacy of intradiskal injection of chymopapain (Chymodiactin) with injection of placebo in patients with a herniated lumbar disk. Patients were randomly assigned to either placebo or drug regimens and followed up for six months. The primary measure of performance was agreement by patient and surgeon that further intervention was not necessary. At any time that patient and investigator agreed that treatment had failed, the patient was classified as a failure and the treatment code was broken. Of 53 placebo-treated patients, 31 failed by this criterion. Of 55 drug-treated patients, 15 failed. Placebo-treated patients who failed were allowed to receive drug treatment, and 29 (91%) of 32 were treated successfully. This study demonstrates that chymopapain is more effective than placebo for treatment of patients with a herniated lumbar disk.