Trial reportJournal of neurology, neurosurgery, and psychiatry1997
A randomised clinical trial comparing interferon-alpha and intravenous immunoglobulin in polyneuropathy associated with monoclonal IgM. The IgM-associated Polyneuropathy Study Group.
Trial report in Journal of neurology, neurosurgery, and psychiatry, 1997. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
17 citing papers in PubMed, 1 synthesis or guideline pooled it, 121 citations in OpenAlex.
- Immunotherapy for IgM anti-myelin-associated glycoprotein paraprotein-associated peripheral neuropathies.The Cochrane database of systematic reviews · 2016Pooled it
- Rituximab in cryoglobulinemic peripheral neuropathy.Journal of neurology · 2009Trial
- Chronic motor neuropathies: response to interferon-beta1a after failure of conventional therapies.Journal of neurology, neurosurgery, and psychiatry · 1999Trial
- A diagnostic score for anti-myelin-associated-glycoprotein neuropathy or chronic inflammatory demyelinating polyradiculoneuropathy in patients with anti-myelin-associated-glycoprotein antibody.European journal of neurology · 2023Article
- Waldenstrom-associated anti-MAG paraprotein polyneuropathy with neurogenic tremor.BMJ case reports · 2019Article
- Advances in the Treatment of Paraproteinemic Neuropathy.Current treatment options in neurology · 2017Review
- Monoclonal Gammopathy-Associated Peripheral Neuropathy: Diagnosis and Management.Mayo Clinic proceedings · 2017Review
- The role of sulfoglucuronosyl glycosphingolipids in the pathogenesis of monoclonal IgM paraproteinemia and peripheral neuropathy.Proceedings of the Japan Academy. Series B, Physical and biological sciences · 2011Review
- Therapy of immune neuropathies with intravenous immunoglobulins.Journal of neurology · 2006Review
- Current therapies for neuromuscular manifestations of paraneoplastic syndromes.Current neurology and neuroscience reports · 2006Article
- Intravenous immunoglobulin in therapy of peripheral neuropathy.Clinical reviews in allergy & immunology · 2005Review
- Treatment of dys-immune neuropathies.Journal of neurology · 2005Review
- [Use of i.v. immunoglobulins in neurology. Evidence-based consensus].Der Nervenarzt · 2004Review
- Autologous peripheral blood stem cell transplantation for peripheral neuropathy secondary to monoclonal gammopathy of unknown significance.Bone marrow transplantation · 2002Article
- Long-term efficacy of interferon-alpha in chronic inflammatory demyelinating polyneuropathy.Journal of neurology · 2002Article
- Relationship between autoantibody specificities and peripheral nervous system involvements.Clinical reviews in allergy & immunology · 2000Review
- Successful treatment of IgM paraproteinaemic neuropathy with fludarabine.Journal of neurology, neurosurgery, and psychiatry · 1999Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectivesThe polyneuropathy associated with a monoclonal IgM directed to the myelin associated glycoprotein (MAG) is a specific entity with a putative causal link between the IgM and the neuropathy. The small benefit offered by alkylating agents or plasma exchanges in these patients justifies the search for alternative treatments.
methodsA 12 month multicentre, prospective, randomised, open clinical trial was carried out comparing intravenous immunoglobulin (IVIg; 2g/kg and then 1 g/kg every three weeks) and recombinant interferon-alpha (IFN-alpha; 3 MU/m2 subcutaneously three times weekly). The main end point was a clinical neuropathy disability score (CNDS) after six months of treatment. Twenty patients were enrolled; 10 were assigned to IVIg and 10 to IFN-alpha.
resultsAt six months, one out of 10 patients treated with IVIg had a CNDS improvement of more than 20% whereas eight out of 10 patients treated with IFN-alpha had such an improvement (P=0.005). The mean CNDS worsened by 2.3 (SD 7.6) (8%) in the IVIg group whereas it improved by 7.5 (SD 11.1) (31%) in the IFN-alpha group (P=0.02). This improvement persisted after 12 months and was mainly related to an improvement of the sensory component (P=0.02) whereas the motor component was unchanged (P=0.39). Electrophysiological data did not show improvement of motor nerve conduction velocities whereas sensory nerve conduction velocities improved in the upper limbs. A decrease in the level of the monoclonal IgM was seen in two patients treated with IFN-alpha. At the end of the treatment, antibody activity to MAG was still detected in the serum of all patients.
conclusionIVIg, as used in this study, did not improve patients with polyneuropathy and monoclonal IgM. By contrast, although its mechanism of action remains to be fully elucidated, IFN-alpha was effective in eight out of 10 patients at six months.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.