Vector-borne Infection,
Research, Analysis, Strategy

Notes on:

Randomised Trial of Longer-Term Therapy for Symptoms Attributed to Lyme Disease.

Anneleen Berende, M.D., Hadewych J.M. ter Hofstede, M.D., Ph.D., Fidel J. Vos, M.D., Ph.D.,
Henriët van Middendorp, Ph.D., Michiel L. Vogelaar, M.Sc., Mirjam Tromp, Ph.D., Frank H. van den Hoogen, M.D., Ph.D., A. Rogier T. Donders, Ph.D., Andrea W.M. Evers, Ph.D., and Bart Jan Kullberg, M.D., Ph.D. 2016.

New England Journal of Medicine. March 31, 2016 vol. 374 no. 13

The authors state:
"The raw SF-36 physical component summary score was transformed into a norm-based T-score (range, 15 to 61), with a mean (+-SD) score of 50+-10 in the general population (higher scores indicate a better physical quality of life)."

The author's explanation for presenting data in a non-standard format does not make sense. Researchers do not usually try to minimise a treatment effect. Most researchers trialling a drug would be delighted if their test produced such definitive benefits.

Published data followed by chart with the same data adjusted to match the 0 to 100 range in common usage:

"Main secondary outcomes were physical and mental aspects of health-related quality of life, as assessed with the use of the RAND SF-36,11 and fatigue, as assessed with the use of the fatigue severity scale of the Checklist Individual Strength, on which scores range from 8 to 56, with higher scores indicating more fatigue15 (Table 1)."

Published data followed by chart with the same data adjusted to match the 0 to 100 range in common usage:

The so-called 'Placebo' group, as with the other groups, were given 2 weeks of intravenous antibiotics - a potent antimicrobial regime sometimes used for Lyme neuroborreliosis, BEFORE the experiment started. Evidently, all the participants not only benefited from the powerful antibiotic intervention, but the improvements had a lasting effect.

Aside from the fact that the researchers sabotaged their own stated objectives by making the 'Placebo group' a 'Treatment group', their data shows that intravenous antibiotics have a dramatic and lasting effect on people with chronic Lyme borreliosis symptoms.

The researcher's explanation for sabotaging the trial was that not treating the placebo group would be unethical. This ridiculous claim is indefensible. A placebo group is common practice in drug trials and participants are sometimes informed that the Placebo Group will receive the same treatment at the end of the trial if it is safe and beneficial. In Berende et al, the average period of persistent symptoms experienced by participants was 2 years and the duration of the 'treatment arms' was only 12 weeks, not long for participants in the Placebo Group to wait in the context of their chronic symptoms, especially as it is unlikely that any of the participants would have received intravenous antibiotics without participating. No ethics committee anywhere, would deny approval based upon asking the placebo group to wait a mere 3 months before they could have their treatment. Therefore crying 'ethics' is not simply unjustified, it is unethical. It destroyed the validity of the trial, falsified the data and misrepresented the participant's illness and treatment effect. It also misleads anyone who does not read the published account carefully. This is not science, it is propaganda.

An Ethics Committee approved treatment of participants with intravenous antibiotics when it appears that without participation, they would not otherwise have received that or any other antimicrobial treatment.

"The trial was approved by the medical ethics review committee Commissie Mensgebonden Onderzoek regio Arnhem-Nijmegen. The study was conducted in accordance with the principles of the most recent version of the Declaration of Helsinki and the International Conference on Harmonisation guidelines on Good Clinical Practice."

Yet Berende et al would have us believe that they would not get Ethical approval if they withheld the risky and non-evidence-based treatment from the Placebo Group, they state:

"We chose not to include a study group that received only placebo because it was judged to be unethical to withhold treatment from patients who might have an infection at baseline that had not yet been treated. We selected ceftriaxone because it is considered the treatment of choice for disseminated Lyme disease."

So according to Berende et al, it is unethical NOT to treat people with intravenous antibiotics when they have persistent symptoms and suspected disseminated Lyme borreliosis. The author's research data supports their ethical views - because intravenous antibiotics clearly benefited this patient group.

This is very good news for patients with Chronic Lyme Borrliosis, many of whom are in conflict with their doctors and other medical authorities because they cannot get ANY treatment at all.