TGI Friday! Our weekly round-up of research abstracts and related items | 15 February 2013

From Arthritis and Rheumatism, 28 January 2013.

Low-dose naltrexone for the treatment of fibromyalgia: Findings of a small, randomized, double-blind, placebo-controlled, counterbalanced, crossover trial assessing daily pain levels†

Jarred Younger*, Noorulain Noor, Rebecca McCue, Sean Mackey
Department of Anesthesia, Stanford University School of Medicine, 780 Welch Road, Suite 207F, Palo Alto, CA 94304-1573

Abstract

OBJECTIVE

To determine whether low dosages (4.5 mg/day) of naltrexone reduce fibromyalgia severity as compared with the nonspecific effects of placebo. In this replication and extension study of a previous clinical trial, we tested the impact of low-dose naltrexone on daily
self-reported pain. Secondary outcomes included general satisfaction with life, positive mood, sleep quality, and fatigue.

METHODS

Thirty-one women with fibromyalgia participated in the randomized, double-blind, placebo-controlled, counterbalanced, crossover study. During the active drug phase, participants received 4.5 mg of oral naltrexone daily. An intensive longitudinal design was used to measure daily levels of pain.

RESULTS

When contrasting the condition end points, we observed a significantly greater reduction of baseline pain in those taking low-dose naltrexone than in those taking placebo (28.8% reduction versus 18.0% reduction; P = 0.016). Low-dose naltrexone was also associated with improved general satisfaction with life (P = 0.045) and with improved mood (P =
0.039), but not improved fatigue or sleep.

Thirty-two percent of participants met the criteria for response (defined as a significant reduction in pain plus a significant reduction in either fatigue or sleep problems) during low-dose naltrexone therapy, as contrasted with an 11% response rate during placebo therapy (P = 0.05). Low-dose naltrexone was rated equally tolerable as placebo, and no serious side effects were reported.

CONCLUSION

The preliminary evidence continues to show that low-dose naltrexone has a specific and clinically beneficial impact on fibromyalgia pain. The medication is widely available, inexpensive, safe, and well-tolerated. Parallel-group randomized controlled trials are needed to fully determine the efficacy of the medication.


From BMC Gastroenterology, 12 February 2013 (open access – provisional text).

Chronic fatigue syndrome 5 years after giardiasis: differential diagnoses, characteristics and natural course

Kristine Mørch(1*), Kurt Hanevik(1,2), Ann C Rivenes(3), Jørn E Bødtker(3), Halvor Næss(4), Bjarte Stubhaug(5), Knut-Arne Wensaas(6,7), Guri Rortveit(6,7), Geir E Eide(6,8), Trygve Hausken(2) Nina Langeland(2)
(1) National Centre for Tropical Infectious Diseases, Department of Medicine, Haukeland University Hospital, Bergen, Norway
(2) Insitute of Medicine, University of Bergen, Bergen, Norway
(3) Division of Psychiatry, Haukeland University Hospital, Bergen, Norway
(4) Department of Neurology, Haukeland University Hospital, Bergen, Norway
(5) Department of Mental Health, Helse Fonna HF, Institute of Clinical Medicine, University of Bergen, Bergen, Norway
(6) Department of Global and Public Health, University of Bergen, Bergen, Norway
(7) Research Unit for General Practice, Uni Health, Bergen, Norway
(8) Centre for Clinical Research, Haukeland University Hospital, Bergen, Norway

Abstract

BACKGROUND

A high prevalence of chronic fatigue has previously been reported following giardiasis after a large waterborne outbreak in Bergen, Norway in 2004. The aim of this study was to describe and evaluate differential diagnoses and natural course of fatigue five years after giardiasis among patients who reported chronic fatigue three years after the infection.

METHODS

Patients who three years after Giardia infection met Chalder’s criteria for chronic fatigue (n=347) in a questionnaire study among all patients who had laboratory confirmed giardiasis during the Bergen outbreak (n=1252) were invited to participate in this study five years after the infection (n=253).

Structured interviews and clinical examination were performed by specialists in psychiatry, neurology and internal medicine/infectious diseases. Fukuda et al’s 1994 criteria were used to diagnose chronic fatigue syndrome (CFS) and idiopathic chronic fatigue (ICF). Self-reported fatigue recorded with Chalder Fatigue Questionnaire three and five years after infection were compared.

RESULTS

53 patients were included. CFS was diagnosed in 41.5% (22/53) and ICF in 13.2% (7/53). Chronic fatigue caused by other aetiology was diagnosed in 24.5% (13/53); five of these patients had sleep apnoea/hypopnoea syndrome, six had depression and five anxiety disorder, and among these two had more than one diagnosis. Fatigue had resolved in 20.8% (11/53). Self-reported fatigue score in the cohort was significantly reduced at five years compared to three years (p<0.001). CONCLUSION The study shows that Giardia duodenalis may induce CFS persisting as long as five years after the infection. Obstructive sleep apnoea/hypopnoea syndrome, depression and anxiety were important differential diagnoses, or possibly comorbidities, to post-infectious fatigue in this study. Improvement of chronic fatigue in the period from three to five years after giardiasis was found.


From Physiotherapy, 5 February 2013 (e-published ahead of print).

The development of an activity pacing questionnaire for chronic pain and/or fatigue: a Delphi technique.

Antcliff D, Keeley P, Campbell M, Oldham J, Woby S.
Pennine Acute Hospitals NHS Trust, North Manchester General Hospital, Manchester M8 5RB, UK; School of Nursing, Midwifery and Social Work, University of Manchester, Manchester M13 9PL, UK.

Abstract

OBJECTIVE Activity pacing is frequently advised as a coping strategy for the management of chronic conditions (such as chronic low back pain, chronic widespread pain and chronic fatigue syndrome/myalgic encephalomyelitis).

Despite anecdotal support for activity pacing, there is limited and conflicting research evidence into the efficacy of this strategy. There is no consensus on the interpretation of ‘pacing’ due to diverse descriptions, including strategies that encourage both increasing and decreasing activities.

Furthermore, at present, there are few validated scales to measure how patients pace
their activities. The aim of this study was to undertake the first stage in the development of a comprehensive tool that assesses the multi-faceted nature of pacing among patients with chronic conditions.

DESIGN

Three-round Delphi technique.

PARTICIPANTS

Expert panel based in the UK including patients and clinicians.

RESULTS

The 42 participants who completed three rounds of Delphi included 4 patients, 3 nurses, 26 physiotherapists and 9 occupational therapists. The 38 questions that reached consensus to be included in the questionnaire encompassed a number of different facets of pacing, for example, breaking down tasks, not over-doing activities, and gradually increasing activities.

CONCLUSIONS

To our knowledge, this is the first study that has engaged both patients and clinicians in a Delphi technique to develop an activity pacing questionnaire. In contrast to existing pacing scales, our questionnaire appears to contain a number of distinct facets of pacing. Further study is being undertaken to engage patients in the exploration of the validity, reliability and acceptability of the questionnaire.


Research Article | Featured in PLOS Clinical Trials, 18 January 2013 (open-access, peer-reviewed)

Misrepresentation of Randomized Controlled Trials in Press Releases and News Coverage: A Cohort Study

Ame ́lie Yavchitz(1,2,3), Isabelle Boutron(1,2,3*), Aida Bafeta(1,2,3), Ibrahim Marroun(4), Pierre Charles(4), Jean Mantz(5), Philippe Ravaud(1,2,3)

(1)INSERM, U738, Paris, France,
(2)Centre d’E ́pide ́miologie Clinique, AP-HP (Assistance Publique des Hoˆpitaux de Paris), Hoˆpital Hoˆtel Dieu, Paris, France,
(3)Universite ́ Paris Descartes, Sorbonne Paris Cite ́, Faculte ́ de Me ́decine, Paris, France, (4)Department of Internal Medicine, Hoˆpital Foch, Suresnes, France, 5Department of Anesthesiology and Critical Care, Beaujon University Hospital, Clichy, France

Abstract

BACKGROUND

Previous studies indicate that in published reports, trial results can be distorted by the use of “spin” (specific reporting strategies, intentional or unintentional, emphasizing the beneficial effect of the experimental treatment). We aimed to (1) evaluate the presence of “spin” in press releases and associated media coverage; and (2) evaluate whether findings of randomized controlled trials (RCTs) based on press releases and media coverage are misinterpreted.

METHODS AND FINDINGS

We systematically searched for all press releases indexed in the EurekAlert! database between December 2009 and March 2010. Of the 498 press releases retrieved and screened, we included press releases for all two-arm, parallel-group RCTs (n = 70). We obtained a copy of the scientific article to which the press release related and we systematically searched for related news items using Lexis Nexis.

“Spin,” defined as specific reporting strategies (intentional or unintentional) emphasizing the beneficial effect of the experimental treatment, was identified in 28 (40%) scientific article abstract conclusions and in 33 (47%) press releases. From bivariate and multivariable analysis assessing the journal type, funding source, sample size, type of treatment (drug or other), results of the primary outcomes (all nonstatistically significant versus other), author of the press release, and the presence of “spin” in the abstract conclusion, the only factor associated, with “spin” in the press release was “spin” in the article abstract conclusions (relative risk [RR] 5.6, [95% CI 2.8–11.1], p<0.001). Findings of RCTs based on press releases were overestimated for 19 (27%) reports. News items were identified for 41 RCTs; 21 (51%) were reported with “spin,” mainly the same type of “spin” as those identified in the press release and article abstract conclusion. Findings of RCTs based on the news item was overestimated for ten (24%) reports. CONCLUSION “Spin” was identified in about half of press releases and media coverage. In multivariable analysis, the main factor associated with “spin” in press releases was the presence of “spin” in the article abstract conclusion.


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