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O'heany. According to the Criteria of Dr. Reiffen- Careful Investigation; It Certainly Merited Publica- Stein, Dr

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O'heany. According to the Criteria of Dr. Reiffen- Careful Investigation; It Certainly Merited Publica- Stein, Dr 3. 224 CORRESPONDENCE Jan.Canad.25, Med.1969,Ass.vol. 100 O'Heany. According to the criteria of Dr. Reiffen- careful investigation; it certainly merited publica- stein, Dr. O'Heany's study would fall into Category tion; and his findings stand a good chance of holding I, a dismal fate indeed. The purpose of this letter is up in clinical practice. It would be wrong, therefore, to argue the point that Dr. O'Heany's report, al- in my view, to consider this study a poor one, which though indeed Category I ("No controls"), is far would be the case were Dr. Reiffenstein's criteria from being a study without value, and, by extension, to be applied, to the exclusion of other considera- to suggest that Dr. Reiffenstein's conclusions (which, tions. Not all studies are perfect, of course, and the of course, were not directed towards Dr. O'Heany's present study could indeed have been improved by study personally) are too simplicistic. I hope Dr. the use of a standard therapy as control, or even O'Heany will not object to my using his article had some indication been given by the author of the to illustrate my thesis (particularly since most of rate of remission seen with other treatment, for the what I have to say about it is favourable). benefit of readers who are not gynecologists. In the same conciliatory vein, let me say to Dr. Surveys such as Dr. Reiffenstein has made are Reiffenstein that I have too much respect for him, extremely interesting, but I feel they could be im- and for the aims of his student program, with which proved by the application of a broader range of I became familiar as the former Medical Director criteria, more subtle in nature. of a pharmaceutical company, to denigrate the C. WALTER MURPHY, M.D. genuine interest which he has shown over the 430 rue du Bon Secours, years in the proper conduct of clinical trials. I Montreal. would agree with what I take to be his general opinion that there are too many trials, published To the Editor: and unpublished, which are poor, and that many I think that it is very fortuitous that you had the of these could have been materially improved by foresight to include the article "Clinical Trial of a the application of criteria which he describes as Broad-Spectrum Antimicrobial Preparation in Vagin- characteristic of a Category V study. The problem, itis" by T. M. O'Heany immediately preceding the however, is more complicated than it would seem to article by Reiffenstein, Schiltroth and Todd (Canad. be from Dr. Reiffenstein's presentation. There are Med. Ass. J., 99: 1134, 1968). It is unfortunate that some Category I trials which are reliable, and more the Journal did not fully accept the criteria as informative, than some Category V trials, so that originally laid down by Mahon and Daniel in their a count of the published articles falling into the 1964 article concerning drug trials (Ibid., 90: 565, various categories need not necessarily reflect the 1964) and refuse to accept all articles which do not actual quality of contemporary drug trials. meet these criteria. It is not only that they are badly As an illustration of a poor Category V trial I carried out; they are actually misleading to un- can envisage (in fact, I don't have to-I've seen informed practitioners who may come to the con- such studies reported) a comparison between two clusion that a completely uncontrolled drug trial, hypnotic agents, with valid controls, random alloca- such as that reported by Dr. O'Heany, is actually tion of therapy, objective assessment of results and acceptable. statistical analysis, in which one drug is shown to There is no doubt in my mind that if I treated be superior to the other with respect to such cri- with a bland vinegar and water douche 45 patients teria as time of onset of effect, duration of sleep, with non-specffic vaginitis for 30 days, there would etc., but where the conclusion is clinically of no im- be a considerable amount of improvement in their portance since the differences were of such a small symptomatology. order (10 or 15 minutes). Such a study would be T. B. MACLACHLAN, M.D., included in Dr. Reiffenstein's count of articles F.R.C.S. [C], F.A.C.O.G., representing improved standards of reporting, Professor and Head whereas another system of evaluation might well Department of Obstetrics consider it to be the opposite, since, in this illustra- and Gynecology, tion (which I am now inventing), the author would University of Saskatchewan, have failed to stress the clinical unimportance of his Saskatoon, Sask. findings, as opposed to their statistical significance. To return to the example which Dr. O'Heany's study provides us of a Category I trial, the author CLINICAL TRIAL OF A BROAD- described 36 patients with vaginitis ascribable to SPECTRUM ANTIMICROBIAL Trichomonas or Candida, or both, and 9 patients PREPARATION IN VAGINITIS with non-specific vaginitis. Treatment with an anti- microbial preparation was prescribed, together with To the Editor: certain rules of hygiene which may or may not have One is constrained to comment on the report, been followed. The results of treatment in the pa- "Clinical Trial of a Broad-Spectrum Antimicrobial tients with specific vaginitis were assessed by micro- Preparation in Vaginitis", by Dr. Terence O'Heany biological investigation. To consider only these 36 in the issue of December 14 (Canad. Med. Ass. I., patients, complete clinical cure was reported in 30 99: 1131, 1968). after one week, and the cure was maintained for at The author makes a number of assumptions which least one month in all but one patient. Dr. are not proven, and suggests a policy of treatment O'Heany's report is by all appearances that of a likely to lead to disappointment. Canad. Med. Ass. J. CORRESPONDENcE 225 Jan. 25. 1969, vol. 100 In the first place, he suggests that "infectious REFERENCES vaginitis may be caused by many different patho- 1. ROBINSON, S. C. AND MIRCHANDANI, G. P.: Amer. J. vaginal Ob8tet. Gvnec., 91: 1005, 1965. gens". If by infectious vaginitis he means 2. SLOTNICK, I. I., HILDEBRANDT, B. 3. AND PRYSTOWSKY. discharge accompanied by some of the classical H.: Obstet. Gynaec., 21: 312, 1963. 3. ROBINSON, S. C. AND MIRCHANDANI, G.: Amer. J. Ob- symptoms of pruritus, dysuria, dyspareunia and of- stet. Gytec., 93: 502, 1965. fensive odour, our observations on many thousands 4. LENIRE, S.: G'anad. Med. Ass. ,T., 99: 211, 1968. of cases,1 supported by Slotnick, Hildebrandt and Prystowsky,2 suggest that it is exceedingly rare in the reproductive age group for vaginitis to occur IDENTIFICATION OF UNIDENTIFIED except due to Trichomonas vaginalis, Candida albi- TABLETS AND CAPSULES cans, or both. To the Editor: The author states that the multiplicity of agents Regarding your editorial on identification of tab- makes accurate diagnosis important to ensure ade- lets and capsules (Canad. Med. Ass. J., 99: 626, quate treatment, but goes on to. advocate a shot- 1968), I would certainly support the need and gun type of therapy which ignores the true etiolo- eventual goal to which you allude-a uniform im- gical facts. It is now generally accepted that tricho- print system as urged by Whitney1 and Collier.2 monal vaginitis is generally (if not always) a ye- nereally transmitted disease. This being the case, it In the interim, I would only warn about the effi- is appropriate to treat both partners, and eradicate cacy of any identification system based solely on all sources of the infection. At present, oral metro- physical characteristics of the unknown. Hefferren3 nidazole is the only drug available which will safely advocated such an approach in 1962. In our hands, it simply didn't work at . Almost half of the do the job.8 attempted identification, (44%) were erroneous, with Candida albicans, on the other hand, is trans- the plain white unknown tablet being a particularly mitted by direct contact, by way of the alimentary elusive culprit. In sharp contrast, the imprint system tract to the vagina or, less commonly, by venereal led to a 96% correct identification and in two-hun- contact with uncircumcised males. While many time. chlordantoin, dredths of the agents (e.g. nystatin, amphotericin B, My point is that not simply is the non-imprint candicidin, pimafucin, to name only a few) are serve effective against Candida albicans in vitro, and often method unworkable, but tolerance of it may re- only to delay acceptance and implementation of the in vivo, treatment may be discouraging owing to imprint technique. Action and not simply discussion, infection, or failure to respond even to long-term to be supported. therapy.4 The sulfanilamide, arninacrine, allantoin then, is the underlying theme cream tested by Dr. O'Heany gives results com- WILLIAM 0. ROBERTSON, M.D., parable to these. Associate Dean We suggest it is wiser to use a single drug, pro- School of Medicine, longing topical treatment, if necessary, to two or University of Washington, even three months, concurrently trying to remove Seattle, Wash. 98105. sources of reinfection by antiseptic soap, oral anti- mycotic drugs, and rendering the environment less REFERENCES favourable to the organism (e.g. controlling dia- 1. WHITNEY, 3. D. W.: Br.t. Med. J., 1: 50, 1960. betes). 2. COLLIER, W. A. L.: Lancet, 1: 473, 1962. 3. HEFFEREEN, 3. 3.: J.A.M.A., 182: 1145, 1962. Finally, the author refers to nine cases of "non- 4. CALDWELL, 3.
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