Double-blind, placebo controlled study of ranitidine (Zantac®) for gastroesophageal reflux symptoms during pregnancy

Larson, Janet D.; Patatanian, Edna; Miner, P; Rayburn, William F.; Robinson, Mark

doi:10.1016/s0002-9378(97)80122-6

Cited by 4 publications

(3 citation statements)

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“…Studies were excluded for a number of reasons. One study (Hey 1978) did not focus on study outcomes; four studies used cross-over designs but did not report findings for the first stage of the trial (Atlay 1978; Briggs 1972; Carne 1964; Larson 1997); the remaining studies were excluded because they had high attrition rates or did not present usable data on review outcomes. In the study by Lang 1989 attrition rates at two weeks’ follow up were 38%; for the Shaw 1978 study attrition rates were 24%, with greater loss to follow up in the control group; and in the Brunclik 1988 study 20% of women were excluded after randomisation, the reason for half of the exclusions was that women were not fully compliant with the study protocol.…”

Section: Resultsmentioning

confidence: 99%

“…No data reported for the first stage of the study Hey 1978 Study focusing on gastric sphincter pressure. No data reported for review outcomes Kovacs 1990 No usable data on review outcomes. Lang 1989 High post-randomisation attrition rates (38% lost to follow up by 2 weeks) Larson 1997 Cross-over design. No data for the first stage of the study. Ranchet 1990 Not clear whether this was a RCT.…”

Section: Characteristics Of Included Studies [Ordered By Study Id]mentioning

confidence: 99%

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Interventions for heartburn in pregnancy

Dowswell

Neilson²

2008

Cochrane Database of Systematic Reviews

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Background-Heartburn is a common symptom in pregnancy affecting up to 80% of women in the third trimester. The reasons for the increase in symptoms in pregnancy are not well understood, but the effects of pregnancy hormones on the lower oesophageal sphincter and gastric clearance are thought to play a part. A range of interventions have been used to relieve symptoms including advice on diet and lifestyle, antacids, antihistamines, and proton pump inhibitors. The safety and effectiveness of these interventions to relieve heartburn in pregnancy have not been established.

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Section: Resultsmentioning

confidence: 99%

Section: Characteristics Of Included Studies [Ordered By Study Id]mentioning

confidence: 99%

Interventions for heartburn in pregnancy

Dowswell

Neilson²

2008

Cochrane Database of Systematic Reviews

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“…[10] Another placebo-controlled study in pregnant women carried out by Larson J et al reported that Ranitidine HCl 150 mg taken twice daily showed better results than Ranitidine HCl 300 mg taken once daily. [17] The GSAS score measures 15 specific symptoms, distress, and quality of life of patients with GERD. The GSAS scores were significantly reduced in all three ARMs from baseline to after 4 weeks.…”

Section: Discussionmentioning

confidence: 99%

A Prospective, Multicentric, Post Marketing Surveillance to Evaluate Efficacy & Safety of Ranitidine HCl (150 & 300 mg IR/CR) in Indian Patients with Gastroesophageal Reflux Disease (PROGRADE)

Shukla,

Awasthi,

Rao

et al. 2023

OJGas

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Purpose: Ranitidine hydrochloride (HCl) remains an important medication for treating acid-peptic ailments such as Gastroesophageal reflux disease (GERD). The main objective of this Post Marketing Surveillance (PMS) clinical study was to test the efficacy and safety of Ranitidine HCl in Indian patients suffering from GERD. Patients and Methods: Data of 2446 patients (1307 males; 1121 females) from 21 centers across India were analyzed. Patients received either of the three treatments: Ranitidine HCl 150 mg twice a day (BID) (ARM-A), Ranitidine HCl 300 mg once daily (OD) or BID (ARM-B), and Ranitidine HCl 300 mg OD (ARM-C). Gastroesophageal Reflux Disease Symptom Assessment Scale (GSAS) score and Heartburn Severity score were used to assess the drug's efficacy. The adverse events reported by patients or investigators were analyzed to assess the safety profile of Ranitidine. Results: Of the 2446 subjects screened, 2428 were enrolled.

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Interventions for heartburn in pregnancy

Phupong

Hanprasertpong

2015

Cochrane Database of Systematic Reviews

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There are no large-scale RCTs to assess heartburn relief in pregnancy. This review of nine small studies (which involved data from only four small studies) indicates that there are limited data suggesting that heartburn in pregnancy could be completely relieved by pharmaceutical treatment. Three outcomes were assessed and assigned a quality rating using the GRADE methods. Evidence from two trials for the outcome of complete relief of heartburn was assessed as of moderate quality. Evidence for the outcomes of partial heartburn relief and side effects was graded to be of very low quality. Downgrading decisions were based in part on the small size of the trials and on heterogenous and imprecise results.There are insufficient data to assess acupuncture versus no treatment and no data to assess other comparisons (miscarriage, preterm labour, maternal satisfaction, fetal anomalies, intrauterine growth restriction, low birthweight).Further RCTs are needed to fully evaluate the effectiveness of interventions for heartburn in pregnancy. Future research should also address other medications such as histamine 2-receptor antagonists, promotility drugs, proton pump inhibitors, and a raft-forming alginate reflux suppressant in treatment of heartburn in pregnancy. More research is needed on acupuncture and other complimentary therapies as treatments for heartburn in pregnancy. Future research should also evaluate any adverse outcomes, maternal satisfaction with treatment and measure pregnant women's quality of life in relation to the intervention.

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Double-blind, placebo controlled study of ranitidine (Zantac®) for gastroesophageal reflux symptoms during pregnancy

Cited by 4 publications

References 0 publications

Interventions for heartburn in pregnancy

Interventions for heartburn in pregnancy

A Prospective, Multicentric, Post Marketing Surveillance to Evaluate Efficacy & Safety of Ranitidine HCl (150 & 300 mg IR/CR) in Indian Patients with Gastroesophageal Reflux Disease (PROGRADE)

Interventions for heartburn in pregnancy

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Double-blind, placebo controlled study of ranitidine (Zantac®) for gastroesophageal reflux symptoms during pregnancy

Cited by 4 publications

References 0 publications

Interventions for heartburn in pregnancy

Interventions for heartburn in pregnancy

A Prospective, Multicentric, Post Marketing Surveillance to Evaluate Efficacy &amp; Safety of Ranitidine HCl (150 &amp; 300 mg IR/CR) in Indian Patients with Gastroesophageal Reflux Disease (PROGRADE)

Interventions for heartburn in pregnancy

Contact Info

Product

Resources

About

A Prospective, Multicentric, Post Marketing Surveillance to Evaluate Efficacy & Safety of Ranitidine HCl (150 & 300 mg IR/CR) in Indian Patients with Gastroesophageal Reflux Disease (PROGRADE)