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A randomized double-blind pilot study comparing Doloteffin and Vioxx in the treatment of low back pain - PubMed (opens in a new tab)

pubmed.ncbi.nlm.nih.gov · 2001-01-01

Short answerEvidenceSource

Short answer

Supported

Supported.

The story matches what the study reports.

  • 1 supported

Checked against the study summary. The full text wasn't available, so some details couldn't be settled either way.

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1

The story

A randomized double-blind pilot study comparing Doloteffin and Vioxx in the treatment of low back pain - PubMed

pubmed.ncbi.nlm.nih.gov · 2001-01-01

The story’s checkable claims.

Read the original story (opens in a new tab)
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Source paper

Source layer

The 25 papers the story cites

Source study separated from background citations.

The research anchor for the report.

Then inspect each claim

Evidence layer

Claim by claim

Each claim gets a verdict. Expand it to see the evidence directly below.

1 claim in this story

Showing all 1 claimChoose a verdict to focus the list.

Claim 1 of 1SupportedThis was a randomized, double-dummy, double-blind pilot study of acutely exacerbated low back pain comparing Doloteffin, a proprietary extract of Harpagophytum, with rofecoxib (Vioxx), a COX-2 inhibitor.View evidenceHide evidence

Why this verdict

The paper profile supports the story’s description of the study as a randomized, double-dummy, double-blind pilot trial in acutely exacerbated low back pain comparing Doloteffin, a Harpagophytum extract, with rofecoxib, identified in the profile as a COX-2 inhibitor. The abstract-level profile also supports the 6-week comparative-trial framing. Although the claim is labeled with causal strength in the StoryPresentation metadata, the text itself is primarily a study-design/intervention-description claim rather than an efficacy-causation claim.

1

Study evidence

Randomized 44 per group; completers: 43 PAID (Doloteffin) and 36 NSAID (rofecoxib).

“This randomized, double-dummy, double-blind pilot study of acutely exacerbated low back pain”
Then look for missing context

Context layer

What the story left out

Important study details the story did not include.

  • High variability in outcome measures limited precision of effect estimates.

    The profile reports large standard deviations and lists high variability as a limitation. The story does not mention this limitation, although it helps explain why the pilot could not establish equivalence.

    From Randomized double-dummy double-blind pilot RCT (parallel groups)

4 things the story did carry across
  • Randomized, double-dummy, double-blind pilot RCT in acutely exacerbated low back pain comparing Doloteffin/Harpagophytum extract with rofecoxib for 6 weeks.
  • The study was intended to inform a definitive comparison and estimate effect sizes/variability rather than establish equivalence in the pilot sample.
  • No significant intergroup differences were demonstrable in the reported outcomes.
  • Small pilot sample and underpowering to establish equivalence.
Then read the study layer

Study layer

Study at a glance

Scan the study first. Expand only the parts you want to inspect.

Pieces of work

3

Evidence read

study summary

Lead result

human in vivo

1Lead resulthuman in vivoCompare the efficacy of Doloteffin (Harpagophytum extract) versus rofecoxib (COX-2 inhibitor) for acutely exacerbated low back pain over 6 weeks, and estimate effect sizes/variability to inform a definitive trial and choice of primary outcome.Randomized double-dummy double-blind pilot RCT (parallel groups)Expand

In plain English

Randomized, double-dummy, double-blind pilot RCT (6 weeks) comparing Doloteffin (Harpagophytum extract; daily dose containing 60 mg harpagoside) versus rofecoxib 12.5 mg/day in acutely exacerbated low back pain. Forty-four patients were randomized to each arm; 43 PAID and 36 NSAID patients completed the study. Multiple patient-reported outcomes and responder-style summaries were collected to estimate effect sizes and variability for planning a definitive trial. No significant between-group differences were demonstrable in the reported outcomes; authors conclude much larger samples would be required to demonstrate equivalence.

Key findings

  • Randomized 44 per group; completers: 43 PAID (Doloteffin) and 36 NSAID (rofecoxib).
  • No pain without rescue medication for ≥5 days of week 6: 10 patients in PAID vs 5 in NSAID.Counts: 10 vs 5
“This randomized, double-dummy, double-blind pilot study of acutely exacerbated low back pain”
What this piece can’t prove
  • Pilot sample size is small and underpowered to establish equivalence between treatments; authors state large samples would be required.
  • High variability in outcomes (large SDs reported) limits precision of effect estimates from this sample.
  • Rescue medication (tramadol) use differed between groups (21 vs 13 users) and may confound pain outcome comparisons; abstract does not report adjusted analyses.
  • Incomplete reporting in abstract: details of randomization method, allocation concealment, statistical tests, confidence intervals, and reasons for differential dropout are not provided.
2human in vivoCharacterize and compare rescue analgesic (tramadol) use between treatment groups during the trial period.Randomized, double-dummy, double-blind pilot interventional trialExpand

In plain English

In this 6-week randomized, double-dummy, double-blind pilot trial comparing Doloteffin (PAID group) and rofecoxib (NSAID group), rescue analgesic tramadol was permitted (up to 400 mg/day). The authors report that tramadol was used by 21 PAID patients and 13 NSAID patients; no statistical test or p-value for this between-group difference is reported in the abstract.

Key findings

  • Tramadol use during the trial was reported for 21 patients in the Doloteffin (PAID) group and 13 patients in the rofecoxib (NSAID) group.
“All were allowed rescue medication of up to 400 mg/day of tramadol.”
What this piece can’t prove
  • Unclear whether tramadol-use counts refer to all randomized patients or only study completers.
  • No information on cumulative dose, number of days of use, or timing relative to outcome assessments.
  • Small pilot sample limits precision and precludes definitive conclusions about between-group differences in rescue-analgesic use.

1 further detail could not be confirmed from the summary.

3human in vivoAssess and compare safety/adverse effects and their attribution to study medications in both groups.Randomized double-dummy, double-blind pilot trialExpand

In plain English

In this 6-week randomized, double-dummy, double-blind pilot trial comparing Doloteffin (PAID group) and rofecoxib (NSAID group), adverse events were reported and partially attributed to study medications. Fourteen patients in each group experienced a total of 39 adverse effects; 28 of these were judged at least partly attributable to the study medications (13 attributable events in the PAID group, implying 15 in the NSAID group). Rescue tramadol use was reported in 21 PAID and 13 NSAID patients. The abstract provides counts and attribution judgments but gives limited detail on severity, timing, or the criteria used for attribution.

Key findings

  • Fourteen patients in each group experienced 39 adverse effects in total; 28 of these adverse effects were judged to some degree attributable to the study medications, with 13 attributable events reported in the PAID group.14 patients per group; 39 total adverse effects; 28 attributable (13 in PAID, 15 in NSAID).
  • Use of rescue analgesic (tramadol) differed between groups: 21 PAID patients used tramadol versus 13 NSAID patients.21 vs 13 patients used tramadol.
“Fourteen patients in each group experienced 39 adverse effects, of which 28 (13 in PAID) were judged to some degree attributable to the study medications.”
What this piece can’t prove
  • Small sample size and incomplete follow-up in the NSAID arm (36 completions vs 43 PAID completions) limit interpretability of between-group differences in harms.

2 further details could not be confirmed from the summary.

Finally, the search trail

Method layer

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Papers considered

The selected paper, plus nearby candidates.

PubMed, Crossref, Europe PMC · 24 candidate papers

Candidate

Are non-steroidal anti-inflammatory drugs effective for the management of neck pain and associated disorders, whiplash-associated disorders, or non-specific low back pain? A systematic review of systematic reviews by the Ontario Protocol for Traffic Injury Management (OPTIMa) Collaboration

European Spine Journal : Official Publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society · 2016 · PubMed, Crossref

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And 18 more candidates considered.