Draft synthesis: Human evidence for BPC-157 — submissions
The 4 submissions received, published in full with declared interests and secretariat responses.
§2Submissions and responses
4 submissions were received. Each is published in full below with its declared interest, the secretariat response and the disposition. The Institute publishes submissions it did not accept in the same form as those it did.
A funnel plot is presented for a set too small to interpret it
The respondent submits on the draft synthesis addressing What randomised human evidence exists for BPC-157 in any indication?. This submission concerns the methods rather than the conclusion, on the view that a conclusion is only as good as the search that produced it.
The draft includes a funnel plot for an outcome contributed by fewer than ten studies. The respondent states that asymmetry cannot be assessed reliably at that number and that presenting the plot invites a conclusion the data cannot support.
The respondent proposes that the plot be removed and replaced with a statement that publication bias could not be assessed.
The secretariat accepts this submission. Presenting an uninterpretable graphic is not a neutral act.
The funnel plot is removed for every outcome contributed by fewer than ten studies, and replaced by a statement that small-study effects could not be assessed at that number, together with the count of registered trials identified without posted results.
Patient-reported outcomes are collected by the trials and not reported by the review
The respondent read the draft review of What randomised human evidence exists for BPC-157 in any indication? and has confined this submission to a single matter.
The respondent states that several contributing trials measured quality of life and function and that the review reports neither, having selected outcomes on the basis of what could be pooled.
The respondent proposes that these outcomes be reported narratively where they cannot be pooled.
The secretariat accepts this submission in part. The outcomes are reported narratively. The proposal to pool them is declined because the instruments used are not comparable and pooling would produce a figure with no interpretation.
Patient-reported outcomes measured by any contributing trial are now reported narratively by instrument, with the instrument named and its minimum important difference stated where one is published, and the absence of a pooled estimate explained.
A sponsor trial meeting the eligibility criteria was excluded
Having read the draft synthesis on What randomised human evidence exists for BPC-157 in any indication?, the respondent puts one point to the committee.
The submission is made on behalf of the sponsor. It identifies a completed trial of the sponsor's compound that meets the stated eligibility criteria and does not appear in the included set, and supplies the trial report and the registry record.
The sponsor asks that the trial be included and the estimate recomputed. No view is expressed on the direction the recomputation should take.
The secretariat accepts this submission in part. The trial does meet the criteria and has been included. The recomputed estimate is materially unchanged, which the response states explicitly so that the outcome of the correction is on the record.
The trial is added to the included set, the estimate and the certainty rating have been recomputed, and the screening record now states why the trial was missed, which was a database indexing gap rather than a screening judgement. The submission is identified as an industry submission.
Regulatory assessment documents were not searched
The respondent notes that the review question — What randomised human evidence exists for BPC-157 in any indication? — is answerable only if the contributing trials measured the same thing, and submits with that in view.
The respondent states that regulatory assessment reports frequently contain analyses that never appear in journals, and that a search limited to bibliographic databases will miss them.
The respondent proposes that regulatory documents be searched for every review in the series.
The respondent endorses the general approach taken in submission 003 and asks that it be extended to the matter identified here.
The secretariat accepts this submission in part. Regulatory assessment documents are searched. The proposal that they be treated as equivalent to a full study report is declined, because the level of detail varies and is often insufficient for risk-of-bias assessment.
Published regulatory assessment documents are now searched as a named source, are reported as a distinct evidence class in the included-studies table, and contribute to the assessment while being excluded from pooled estimates where risk of bias could not be assessed from the document.
References cited on this page
References are numbered in order of first citation in this document. Each superscript in the text links to its entry below.
- International Organization for Standardization. ISO/IEC 17025:2017 General Requirements for the Competence of Testing and Calibration Laboratories. ISO/IEC Standard 2017;3rd edition. identifier not held by the Institute
Identifiers are reproduced only where the Institute holds them. Where a digital object identifier or PubMed identifier is not shown, the Institute has recorded the journal and year and has not constructed an identifier.