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Re: Is the surgeon be consealed with the dianogsis?

Dear authors:

I am impressed with your article, because in our country, the major part of surgeons still believe analgesics would mask the physical findings and delay the time of accurate diagnosis.

In your article, I have a question that patients were examined by surgeons not involved in their care while they were waiting for operation. I wondered if the surgeons had already known the diagnosis of patients or if they were concealed? The other question is that if the patients before being scheduled to receive operation had any analgesic or not.

I will be glad to know and that will help me do my job well.

Send letter to journal:
Re: Ethics and analgesia

We were interested to read the article by Amoli et at [1] confirming that morphine reduces pain in patients with acute appendicitis without affecting diagnostic accuracy. Although the trial was said to be carried out according to the Declaration of Helsinki [2], we were concerned that emergency department patients with a clinically convincing presentation of acute appendicitis sufficient to warrant booking for appendicectomy, were randomised to receive morphine, or placebo normal saline.

It may be that standard practice in the study institution currently is not to give any analgesia to patients waiting for appendicectomy, but this was not stated in the paper. Even so, the authors make reference to the wealth of published evidence demonstrating that morphine does not hinder accurate surgical diagnosis, therefore removing any “clinical equipoise” necessary ethically to justify a randomised placebo controlled clinical trial.

The Declaration of Helsinki states: “extreme care must be taken in making use of a placebo-controlled trial and that in general this methodology should only be used in the absence of existing proven therapy”, and: “considerations related to the well-being of the human subject should take precedence over the interests of science and society.” The well-being of these subjects included the provision of adequate analgesia; they should not have been given placebo, and they should not have been studied to answer a question that has already largely been answered.

Secondly, the study was powered only to detect a change in pain as measured by a visual analogue score, rather than to detect a change in diagnostic accuracy. No difference in clinical signs was found between the morphine and control groups, but this is likely to be a type II error, as with only 71 patients enrolled it is unlikely that the study was powerful enough to detect such a difference. Patients were therefore subjected to a trial in which half suffered unnecessary pain, but which was sufficient only to assess whether morphine relieves pain or not. Even if some still believe, despite the evidence [3], that morphine might mask physical signs, no-one disputes that morphine relieves pain.

Ethical approval by a local research ethics committee does not necessarily imply that a study really does meet the scientific and ethical standards demanded by the Declaration of Helsinki, nor therefore by readers of the Emergency Medical Journal.

Giles N Cattermole Colin A Graham Timothy H Rainer

Accident and Emergency Medicine Academic Unit Chinese University of Hong Kong Prince of Wales Hospital Shatin Hong Kong SAR China

[1] Amoli HA, Golozar A, Keshavarzi S, et al. Morphine analgesia in patients with acute appendicits: a randomised double-blind clinical trial. Emerg Med J 2008; 25: 586-9.

[2] World Medical Association. Declaration of Helsinki. Ethical principles for medical research involving human subjects. Ferney-Voltaire: WMA, 2004.