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We are publishing the trial's findings according to the restoring invisible and abandoned trials RIAT initiative because the trial was never published. Each patient was instructed to take 2 tablets at bedtime and 1 additional tablet in the afternoon or morning if needed, for 7 nights. Reported outcomes included the number of hours of nausea reported by patients, the frequency of vomiting reported by patients and the overall efficacy of medication as judged by physicians.
Based on incomplete information, the most common adverse events were apparently drowsiness and fatigue.
There is a high risk of bias in these previously unpublished results given the high attrition rate in a 7 day trial, the lack of prespecified outcomes or analyses, and the exclusion of some data because of questionable data integrity. This is an open access article distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
Data Availability: All relevant data are within the paper and its Supporting Information files. Additional supplementary material is available from Dryad: doi: Funding: The original trial was conducted by Merrell-National Laboratories.
The restorative authors received no project specific funding. Nausea and vomiting during pregnancy NVP is self-limited and often resolves abruptly without treatment around the start of the second trimester [ 2 ]. Symptomatic treatments for NVP include dietary changes such as eating small meals frequently, non-pharmacological treatments such as ginger and pharmacological treatments including antiemetics that are used outside of pregnancy such as antihistamines and metoclopramide [ 3 ].
Doxylamine-pyridoxine is the first-line pharmacological therapy for NVP according to the current guideline by the Society of Obstetricians and Gynaecologist of Canada [ 4 ], Motherisk [ 5 ], and the American College of Obstetricians and Gynecologists [ 6 ]. One prescription for doxylamine-pyridoxine is filled for every two live births in Canada [ 7 ]. There is limited published evidence for the efficacy of doxylamine and pyridoxine according to a recent Cochrane systematic review [ 3 ].
One unpublished study has been referred to in support of the use of the combination of doxylamine and pyridoxine. The website Bendectin. The dose of doxylamine and pyridoxine used in the 8-way trial 10 mg each is the same as that in the currently approved and recommended treatments.
Given the reliance on this unpublished trial and the current common usage of doxylamine and pyridoxine, we are publishing information about this trial according to the restoring invisible and abandoned trials RIAT initiative [ 13 ]. This paper adheres to the reporting standards that ensure accountability outlined in the RIAT initiative methods [ 13 ].
We also contacted the Bendectin Peer Group as well as several other individuals with experience obtaining unpublished data. We reviewed approximately 36 pages of information received from the FDA and approximately 7 pages were related to this trial.
The other pages were apparently about other studies, malformation reports and various correspondences. Some pages contained information that was difficult to read as apparently the information was stored on microfiches. After reviewing the information from the US FDA, we called the FDA to ask if any higher quality reproductions were available or if any further information such as subsequent submissions was available and we were told that we were sent all information relevant to our broad request.
We also obtained pages of information from Health Canada but pages were redacted. The European Medicines Agency informed us that they had no relevant records related to our request. We received no relevant information from Duchesnay following our request. We were unable to contact any of the site investigators listed in the report after searching for their contact information online; we found some indications that many of the investigators have since died.
The Bendectin Peer Group, who were assembled to review the study for the US FDA, were notified by the restorative authors via fax on August 3, and were asked to respond in 30 days.
None declared any intention to restore the record appendix A. As of 25 September , 3 did not respond to our letter and 1 responded but did not register intent to publish the trial. We are now publicly declaring our intention to publish the findings of this clinical trial. The original report of the Bendectin Peer Group study is included in appendix B.
The description of the design and conduct of the study below is based on the information we reviewed. The study used a double blind, multi-centred, randomized controlled study design. Factorial analyses were performed. No sample size calculation was reported. Each patient was instructed to take 2 tablets at bedtime and, if necessary, 1 additional tablet in the morning and in the midafternoon, for 7 nights.
The protocol does not indicate which outcome was the primary outcome and the trial was done before trials were registered prospectively. During the initial visit, the investigator completed and recorded the initial patient evaluation. Each patient was given the baseline card to complete immediately and 7 daily report forms to be completed each day of the intervention.
The importance of completing the form promptly and not waiting until the end of the study to complete all forms was emphasized. At the end of the 7 days of intervention, the patients returned to the investigator who checked the forms for completeness, obtained any additional information and completed a final evaluation.
Adverse events were recorded by physicians when volunteered by participants. Reasons for noncompliance were recorded. Adverse events were apparently recorded in the physician evaluation form. During the initial visit, the investigator enrolled patients into the study and obtained consent. To ensure allocation concealment, a centralised service at Merrell-National Laboratories was used. Medications were identical in appearance and had the coating used for Bendectin.
Each medication was packaged in bottles of 30 tablets and each bottle was labeled with a tear-off label. The sealed tear-off portion contained the identity of the contents. The randomized intervention was to be revealed only after serious problem arose, and after contacting the project monitor at Merrell-National Laboratories. The statistical methods were not reported.
Wherever possible, we also present our estimate of the same results. As original results were presented as percentages, without denominators or numerical results, we used information available elsewhere in the trial report to estimate denominators for each treatment arm and to calculate exact numbers of women with specific outcomes based on reported percentages.
Where we have relied on estimates rather than directly reported data, we have identified estimates as such in the relevant tables. We assume p-values less than 0. We used the Cochrane Risk of Bias tool to assess the quality of the trial [ 16 ].
The two authors each independently made assessments and discussed disagreements. Further changes were made during the peer review process. The trial was conducted before trial registration was routine. We were unable to retrospectively register this trial because the available information collected was insufficient.
The Institutional Review Board details were not available. Information on case reports subsequent to this date will be supplied in a future submission. We report here the findings from the study that is currently referenced in the literature.
We did not obtain any additional clearly relevant information from other sources; a large portion of the information received from Health Canada was redacted. Of the 32 initial clinician investigators of the study, 3 never started the study, 26 terminated or completed their porting, and 3 were still actively collecting data at the time the report was generated.
The results from the original study include the following information for each arm of treatment: severity of nausea or vomiting, prevalence of side effects, overall effectiveness of medication, the number of patients allocated, lost to follow up and completed per protocol.
The number assessed for eligibility is unknown. Data about adverse events were missing for an additional 18 participants. The number randomized to each group was not reported but allocation seems to have been roughly even.
Fig 1 We could not find information about typical baseline characteristics age, parity, duration of pregnancy at enrollment. Baseline symptoms are shown in Table 1. Numbers of participants who were randomized, received intended treatment and were analyzed for the efficacy outcomes. The difference between groups in symptom improvements according to physician evaluation Table 2 and patient symptoms diaries Table 3 were summarized in the review report.
The results are reproduced from the review report and show one-sided p-values and no denominators. We estimated the differences between groups using the available summary information about physician evaluations Tables 4 and 5. We assumed that the number of participants in each group was equal to those who completed the study per protocol and we assumed the reported percentage improvements shown in Tables 2 and 3. We disregarded the missing data for the purposes of the calculation.
No serious adverse effects were reported for any of the medications used in the study. The total number of adverse events and the incidence of the most common adverse events reported are shown in Table 6.
The risk of bias was high in several domains Table 7. The trial predated reporting guidelines and information about several domains was incomplete. The data known to be of questionable integrity was a small fraction of the data included in the available interim analysis and we do not know if problems with the integrity of other data were identified, the reason the final results of the trial are not available or the reason these results were not published previously.
The risk of bias was high in several domains. The US FDA review report for the 8-way study concluded that the combination of doxylamine, pyridoxine and dicyclomine is efficacious in the treatment of NVP and that the efficacious components are likely doxylamine and pyridoxine but not dicyclomine. Several sources have cited this trial in support of doxylamine and pyridoxine for the treatment of nausea and vomiting during pregnancy [ 9 — 12 , 17 ].
Health Canada currently relies on this trial in support of the efficacy of doxylamine and pyridoxine [ 18 ]. A Cochrane review [ 3 ] concluded there was insufficient evidence supporting the efficacy of any particular intervention including doxylamine-pyridoxine.
The information presented here including the risk of bias assessment may be used to decide whether this trial should be included in future systematic reviews. This manuscript and the supporting materials make information about this previously unpublished trial easily available for consideration by regulators, researchers, clinicians and patients. Despite our efforts over several years to obtain available information from regulators and others who might have information about the study, the utility of publishing this information is limited by the lack of some important information including individual participant level data.
Instead of using individual participant level data, we estimated differences between groups using summary data and based on several assumptions.
Other details of the protocol such as how clinicians judged clinical response or the statistical tests performed could not be obtained. The information published here for the first time about this s trial allow for an assessment of the evidence base supporting the use of commonly used agents for nausea and vomiting of pregnancy: doxylamine and pyridoxine.
While the analyzed data indicate differences from placebo for several combinations, the questionable data integrity, high drop-out rate, and other methodological concerns mean that the prescribing of this medication should not be based on this trial. No firm conclusion about the efficacy or safety of doxylamine or pyridoxine can be drawn from the limited available information. The claims about the efficacy of doxylamine and pyridoxine and the clinical practice guidelines and regulatory decisions that are based on this trial should be revisited.
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These are box plot that provide a unique visualisation, summarising all the activity data for a ligand taken from ChEMBL and GtoPdb across multiple targets and species. Click on a plot to see the median, interquartile range, low and high data points. A value of zero indicates that no data are available. A separate chart is created for each target, and where possible the algorithm tries to merge ChEMBL and GtoPdb targets by matching them on name and UniProt accession, for each available species. However, please note that inconsistency in naming of targets may lead to data for the same target being reported across multiple charts. View interactive charts of activity data across species.
Return Home Inxight: Drugs. Search Substances. US Approved Rx Source:. First approved in Source:. Structure Search. Dicyclomine is an anticholinergic tertiary amine used frequently by oral and parenteral route as an effective anti-spasmodic agent. In addition is known, that dicyclomine is also used in morning and motion sickness, dysmenorrheal, intestinal hypermotility. It was shown, that Dicyclomine is a selective M1 and M3 muscarinic receptors antagonist, but os shown pharmacological activity via the M1 receptor.
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The world's first wiki where authorship really matters Nature Genetics, Due credit and reputation for authors. Imagine a global collaborative knowledge base for original thoughts. Search thousands of articles and collaborate with scientists around the globe. Hoffmann, R. A wiki for the life sciences where authorship matters. Nature Genetics Share Send to a friend Share.
Orphenadrine chemical structure Orphenadrine. M03 BC It is also used for treating some aspects of Parkinson's Disease. In addition to muscle-relaxant and antihistaminergic effects, orphenadrine has significant antispasmodic , direct analgesic , and weak to moderate local anaesthetic actions.
Language Label Description Also known as English dicyclomine. PubChem CID. RxNorm ID. World Health Organisation international non-proprietary name. Cholinergic receptor muscarinic 1.
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A more recent article on irritable bowel syndrome is available. Patient Information Handout. Irritable bowel syndrome is the most common functional disorder of the gastrointestinal tract and is frequently treated by family physicians. Despite patients' worries about the symptoms of irritable bowel syndrome, it is a benign condition.