325

ANTIHISTAMINE DRUGSBy R. S. BRUCE PEARSON, D.M., F.R.C.P.

King's College Hospital

Histamine was first isolated from ergot by Bargerand Dale in I9IO. It was soon observed that itsparenteral administration in animals caused effectsresembling those of anaphylaxis (Dale and Laid-law, I9iI). In 1927 Best and others showed thatit occurred naturally in animal tissues. Dragstedt(1945) has summarized the evidence in favour ofhistamine acting as the effective agent in allergy asfollows:

i. That its effects in animals are similar to thoseof anaphylactic shock.

2. That it is present in increased amount inmammalian tissue in anaphylaxis.

3. That many allergic manifestations in manare similar to the effects of released histamine.

4. That antihistamine drugs control many of thesymptoms of allergy.

Lewis (I927), Curry (1946) and Epsteine (I943)have shown that various allergic manifestations,including urticarial wheals and asthma can be re-produced in man by histamine introduced, locally.It is, however, well known that other naturallyoccurring drugs, particularly acetylcholine, mayalso induce asthma in asthmatic subjects.The symptoms produced by injection or in-

halation of histamine are more effectively pre-vented or abolished in animals by antihistaminedrugs than are those caused by anaphylaxis. Inthe same way strips of sensitized guinea pigs' in-testine, or the isolated uterus of a sensitized guineapig, will still contract when brought into contactNwith antigen even after they have been renderedinsensitive to the repeated effects of histamine itself(Schild, 1936; 1949). These apparent incon-sistencies in the action of antihistamine drugs maydepend on whether the histamine is liberated inclose proximity to the sensitive end organs or at adistance so that they must diffuse through thetissues or be carried by the blood stream to theend organs (Dale, 1948). It is also possible thatqualitative differences exist between the effects ofhistamine and anaphylaxis or allergy.

Nature of Antihistamine DrugsAntihistamine drugs can be arranged in three

chemical groupings. I am indebted to Dr.M. J. H. Smith, M.Pharm., F.R.I.C., for thisclassification:-

I. Ethylline-diamine derivatives (Anthisan,Pvribenzamine).

2. Alkylamine derivatives (Benadryl, Antistine).3. Phenindamine derivatives (Thephorin).The following drugs are at present available in

this country:-Anthisan (May and Baker).*Antistine (Ciba).Histostab (Boots).Benadryl (Parke Davis).Histantin (Burroughs Wellcome).Pyribenzamine (Ciba).Phenergan (May and Baker).Thephorin (Roche Products).Numerous other antihistamines are marketed in

America but there is no reason to suppose thatany of them are at present more effective than thoseavailable here.

Mode of ActionAntihistamine drugs are thought to exert their

effect by competing with histamine for the tissuereceptors, thus preventing the normal pharma-cological action of histamine (Gaddum, 1948;Bain, 1949).

Methods of AssessmentAhtihistamine drugs are assessed in the first

instance by their action on animals. *The follow-ingmethods are used:

i. Prevention of histamine flare in guinea pigs.2. Prevention of death from histamine ad-

ministered intraperitoneally, intrabronchially orintravenously (guinea pigs).

3. Prevention of anaphylactic death (guineapigs, rats).

4. Prevention of the action of histamine on in-testinal strips (guinea pigs).

5. Prevention of the effect of antigens on sen-sitized intestinal strips (guinea pigs).

In man their ability to prevent skin reactionscaused by intradermal histamine or atopic extractshas been compared, as has their effect in asthmaproduced artificially by the inhalation of histamine.Finally their value can be e.stimated in the controlof, naturally occurring symptoms of allergy.

* Identical with Neo Antergan (Merck).

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Because of the suggestibility of allergic patients,however, and of the tendency to spontaneous im-provement, great caution must be exercised inassessing the resuilts of treatment.

Relative ValuesThere is no exact parallel between the relative

values of these drugs in animal experiment andhuman allergy. It has been shown that they varywidely in potency when tested against lethal dosesof histamine. A standard protective dose of anthi-san will protect guinea pigs against 124 lethaldoses of histamine, whereas pyribenzamine pro-tects against 37, benadryl against 5 and antistineagainst 2 (Friedlaender, 1948). Phenergan (Hal-pern, I947) is said to prevent the effect of 1,500lethal doses of histamine compared with a com-parable dose of anthisan which protects against8o lethal doses. In their ability to diminish theeffect of intradermal histamine in man the differ-ences between them are less striking although thedrugs are effective in roughly the same order. Inthis respect phenergan is about seven times moreeffective than anthisan (Bain, I949; Bain, et al.,1949).

In clinical allergy the relationship between theaction of the various antihistamine drugs is stillless definite; thus one patient may receive nobenefit from an antihistaminic powerful as judgedbv animal experiment, but may obtain relief fromone far weaker. There is also a great difference inthe duration of the effect of these drugs. Bainhas compared the action of anthisan, phenerganand antistine in reducing the size of histaminewheals in the human skin. The maximum effectof all these drugs is reached 2 to 3 hours afteringestion by mouth; half the maximal effect isstill present after I9 hours in the case of phener-gan, S hours for anthisan and 3 2 hours for antistine(Bain, I949).Side Actions

Antihistamine drugs also exert other pharma-cological effects besides that of antagonizing his-tamine. All possess a strong local anaestheticaction. In most cases they are more potent inthis respect than procaine; thus anthisan is 3.3times as effective in its local anaesthetic action(Graham, I947). Many also have an anti-acetylcholine effect which is not relatted to theirantihistamine activitv. Phenergan, for example,is strongly antihistaminic and also has a potentanti-acetylcholine action; anthisan, which is alsostrongly antihistaminic has only a slight anti-acetylcholine effect, while benadryl, which hlas aweaker antihistamine action, is a more potentantagonist of acetylcholine (Schild, 1949).

Benadryl, anthisan and pyribenzamine pcten-tiate adrenaline in biological preparations;Thephorin, on the contrary, has an anti-adrenalineaction. A hyoscine-like effect which causesdrowsiness is commonly encountered, as is theatropine-like effect which causes dilatation of thepupils and a dry mouth. Anthisan has been shownto act like quinidine on the rabbit's heart (Dewsand Graham, I946). It is therefore evident thatnot all the effects of the antihistamine drugs canbe attributed to their antihistamine activity.

These side actions may be advantageous intreatment-thus the potentiation of adrenaline andthe anti-acetylcholine effect should increase theefficiency of drugs possessing these properties inallergy; the local anaesthetic action is undoubtedlypartly responsible for their anti-pruritic effect, andsedation may be a useful addition to the anti-histamine action at bedtime. In a few patients,however, the side effects are more pronouncedthan the antihistamine action, and may preventtheir continued use. These side effects may besummarized as follows:

SIDE EFFECTS

Affecting Central Affecting Ali-Nervous System mentary Canal Miscellaneous

Drowsiness Nausea Blurred visionFatigue Vomiting PalpitationVertigo Diarrhoea Muscular crampFainting Colic Allergic reactionsNarcolepsy Anorexia includingEpilepsy Dry mouth asthmaInco-ordination ConstipationLoss of memoryParaesthesiaeInsomniaExcitement

Drowsiness is undoubtedly the commonest ofthese symptoms and is often accompanied bygiddiness and fatigue. The highest incidenceseems to occur after benadryl and phenergan, thelowest after antistine; diarrhoea and less oftennausea and vomiting are seen more commonlyafter antistine than is drowsiness (Waldbott andYoung, 1948). Pyribenzamine also causes arelatively high proportion of alimentary tractsymptoms (Loveless and Brown, 1947; McGav-ack, et al., I948). It is interesting to note thatsuccess is claimed in the treatment of various formsof vomiting by antihistamine drugs. Thephorindiffers from the other members of the group inthat restlessness, excitement and insomnia some-times occur and constipation is commoner thandiarrhoea. Intensification of allergic symptomsincluding asthma following the use of anti-

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histamine drugs has been described (Waldbottand Young, I948).

There are considerable variations in the in-cidence of side effects according to differentobservers. Thus after benadryl, Loveless andBrown (I947) found that 6o per cent. of patientscomplained of drowsiness, whereas only 27.5 percent. were affected in a series investigated byMcGavack (i949). The incidence of side effectsis related to the dose employed and there is con-siderable personal variation in sensitivity todifferent drugs. Patients showing side effectswith one may tolerate another satisfactorily.

Side effects tend to diminish with continued useof the drug and they are only seldom severe enoughto prevent further treatment. Drowsiness may becounteracted by amphetamine sulphate, nausea bytaking the drug with food rather than on*an emptystomach. Histamine phosphate has been suggestedas an antidote if side effects are severe, but as theseare probably seldom directly related to the anti-histamine action, it is doubtful if this measurewould be beneficial. Since histamine itself maycause severe' symptoms in allergic individualsits administration might also be harmful. Becauseof the possibility of severe side effects anti-histamine drugs should not be taken for the firsttime shortly before driving a motor vehicle.

Clinical ValueThe antihistamine drugs which were first used

in the atopic diseases have now been employed,with varying success, in a number of apparentlyunrelated conditions. Their value in the atopicdiseases (asthma, rhinorrhoea, urticaria, angeio-neurotic oedema) will first be discussed.

Atopic DiseasesThere is unanimous opinion that these drugs

are most effective in urticaria and angeio-neuroticoedema. Successful treatment in from 70 percent. to ioo per cent. of cases of this type havebeen claimed by various wvorkers (Serafini, I948;Gay, et al., I948; McGavack, et al., I948;Friendlaender, 1949; Bain, et al., 1949; Levin,1949). Some of these series are, however, verysmall and in many there is no differentiation be-tween acute and chronic urticaria; it is wellknown that acute urticaria undergoes spontaneousrecovery very readily and too much attentionshould therefore not be paid to figures relating tothis condition. Chronic urticaria is, on the con-trary, often highly resistant to treatment andsymptomatic relief in adequately supervised casesis therefore very significant. Bain' (i949) claimscomplete or considerable relief in 20 cases treatedwith phenergan prescribed in a single dose of 25to ioo mgm. at night and almost equally good

results with anthisan given in doses of ioo mgm.three or four times 'daily. Good results' are alsoclaimed in rhinorrhoea and hay fever in from 52per cent. to 89 per cent. (Loveless and Brown,1947; McGavack, et al., I948; Waldbott andYoung, 1948; Steinberg and Gottesman, I948;Brown, et al., I948; Friedlaender, I949; Poulsen,I949; Knox, I949). Gay and his co-workers(1948) claim success in these conditions in 68 percent. of 428 cases treated with eight different anti-histamine substances. Different workers adoptdifferent criteria of success, the majority claiming' partial success.' Those who subdivide theircases into ' complete ' and ' partial relief ' seldomclaim more than 20 per cent. of ' completelysuccessful results.Asthma undoubtedly responds less satisfactorily,

probably because factors other than allergy play arelatively more important part in its causation.Some confusion arises from the fact that asthmainduced artificially by inhalation of histamineaerosol can be completely prevented or controlledby antihistamine drugs (Curry, 1946; Herx-heimer, 1949). Unfortunately, naturally occurringasthma is much less susceptible. Partial relief isclaimed in from 4 per cent. to 85 per cent. byvarious authors (Friedlaender, 1948; McGavack,et al., I948; Serafini, I948; Gay, et al., 1948;Waldbott and Young, 1948; Steinberg and Gottes-man, 1948; Herxheimer, 1948; Friedlaender,1949). Gay and his co-workers (I948), usingdummy tablets as a control, claim over 50 per cent.relief in approximately 40 per cent. of 96 patientswho were treated with antihistamine preparations.Hunter and Dunlop (1948), on the other hand,found that when the effects of anthisan anddummy tablets were compared in 35 asthmaticpatients over a period of three months, no lastingbenefit could be shown. They conclude that thereis no indication for the use of antihistamine drugsin asthma and point out that the ' spontaneousfluctuations which occur in the severity and fre-quency of the attacks and the suggestibility of itssufferers to any form of treatment, especially if itis new and administered with impressive gravity,has made asthma the happy hunting ground forthe uncritical therapeutic enthusiast.' Even thosewho believe that these drugs may be of value inasthma expressly state that they are ineffective insevere attacks (Loveless and Brown, 1947; Herx-heimer, I949), or if bronchial infection is present(Levin, 1946). The best results of treatment havebeen observed in mild cases of asthma which aredisturbed by nocturnal wheezing. Phenergan oranthisan whose effects persist for a number ofhours are then of value if taken before retiring atnight. Under these circumstances the sedativeside effects contribute to their therapeutic success.

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DermatosesVarious itching dermatoses including eczema

are said to be relieved by the local or general ad-ministration of antihistamine drugs. There seemsno doubt that these prevent the symptom ofpruritus, and with the cessation of trauma due toscratching, improvement may then take place. Itis possible that the anti-pruritic effect depends ontheir procaine-like rather than the antihistamineaction.

Allergic Reactions to Atopic Extracts, Thera-peutic Agents of Biological Origin and Drugs

In the course of desensitization with extracts ofatopic materials (pollen, horse dander, etc.)general reactions, sometimes of a serious nature,occur from time to time. There is ev;dence thatthe antihistamine drugs are of value in preventingor controlling reactions of this type (Serafini,I948). It is important to realize, however, that ifthe reaction is severe adrenalin is still the mosteffective and the most quickly acting remedialagent. Allergic reactions to biological prepara-tions such as liver extract or insulin may be effec-tively controlled (Arbesman, et al., I946; Hunterand Hill, I947; Leavitt and Gastineau, I947;Klein, 1948; Caryer and Koelsche, 1948). Thesuccessful treatment of urticaria or angeio-neurotic oedema as the result of sensitivity to drugssuch as aspirin or penicillin has been recorded, ashave similar symptoms in serum sickness (Cowan,I949). It is also claimed that the respiratory symp-toms of iodine (Boucher and Lafuma, I948) andthe nausea and vomiting caused by streptomycin(Bignell and Crofton, I949) have been controlled.

ParkinsonismA number of claims concerning the value of

Benadryl in Parkinsonism have been made. Themuscular' rigidity and cramps are said to bechiefly affected, and bedridden patients are statedto have become ambulant (Gerest, et al., I948;Gates, I949; Ryan and Wood, 1949). The effectof treatment is said to reach a maximum after tendays. Solonaceous drugs may be given at the sametime. It seems possible that any benefit observedin this condition depends upon the atropin-hyoscine-like side effects of benadryl.

Nephritis a

An allergic pathogenesis to bacterial productshas long been postulated in acute nephritis. On*this account antihistamine drugs have been usedin its treatment. Craig, Clarke and Chalmers(i949) treated eight children suffering from thiscondition with anthisan and compared the timetaken for the albuminuria to cease with a group ofnine who had not received this treatment. The

average duration of albuminuria was 13 days forthe treated cases and 92 days fbr the controls.

Radiation SicknessIt has been suggested that the symptoms of

radiation sickness may be due to the liberation ofhistamine. Mains (i949) claims that the oral andlocal administration ofbenadryl and pyribenzaminet25 mgm. daily) in 300 patients have reduced thetendency to erythema and desquamation whichoften follows heavy dosage with X-rays. Lof-strom and Nurnberger (1946), also using benadryl,had previously claimed success in relieving thesymptoms caused by X-ray treatment. Hunterand Dunlop (I948), using anthisan in alternatepatients receiving X-ray treatment for carcinomaof the breast, were unable to demonstrate anybenefit frem its use.

Motion SicknessGay and Carliner (I949) have shown in a very

well-controlled experiment conducted on troopscrossing the Atlantic that dramamine (a com-pound of benadryl with theophylline), in dosesof ioo mgm. every five hours, prevented sea sick-ness in almost ioo per cent. of cases. McEvedy(I949), comparing the effect of hyoscine (gr. i/ioo)with anthisan (ioo mgm.), also in a troopship,found that the latter was slightly more effective.Strickland and Hahn (1949) found that dramaminehad some effect in preventing air sickness.

Vomiting of PregnancyVarious workers have suggested that the

toxaemia of pregnancy is the result of an allergicprocess, and that liberation of histamine mightultimately be responsible (Hofbauer, I926;Kapeller and Adler, 194I and I943). Dougray(I949) claims that phenergan 25 mgm. t.d.s. isnearly always effective in controlling the vomitingof pregnancy; some cases however requiredheavier dosage. Anthisan also produced goodresults. Success has been claimed in pregnancyvomiting and other forms of pregnancy toxaemiawith phenergan and antistine.

Prevention of the Common ColdIt is claimed that antihistamine drugs given

within a short time of the onset of a cold arecapable of aborting it (Gordon, 1948; Brewster,1949). Colds commonly abort spontaneously inthe early stages, however, and more controlledtests are necessary before these views are accepted.

Prevention of Side Effects caused by CurareThe use of curare-like compounds in anaesthesia

and particularly in electrical convulsion therapy isnot infrequently associated with bronchospasm,

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excessive bronchial secretion and a well-markedfall in blood pressure. Various antihistaminedrugs, including antistine, anthisan and phener-gan, are said to be effective in preventing the sideeffects of curare and its analogues. These pre-parations were more effective than atropine(Courvoisier and Ducrot, I948; Poulsen, I949).

Time is necessary to show whether the anti-histamine drugs will achieve a permanent place inthe treatment of the conditions to which referencehas been made. Many of these diseases are, likeasthma, subject to natural fluctuations and theeffects of suggestion; too often control cases havenot been adequately studied. Even when anti-histamine drugs are of proven value one must notbe too ready to believe that this is due entirely totheir antihistamine properties since they all havesuch important side effects.

Administration and DosageOral. Antihistamine drugs are most often taken

orally in the form of tablets or capsules. Forchronic or recurrent conditions 150 to 300 mgm.can be given in 24 hours; in single doses 50 to I00mgm. are usual. Antistine (histostab), which isless potent and also has fewer side effects thanmany of the others, is often given in doses of ioo to200 mgm. Phenergan, at present the most potentof these drugs, may be effective in 25 or 50 mgm..doses; because its action is long lasting, one ad-ministration in 24 hours may be sufficient. Con-siderably larger doses of many of these drugs, up to1,200 mgm. per day have been given (Bain, et al.,I948; Knox, 1949; Southwell, I949), but it is un-wise to exceed the doses mentioned until it iscertain that the patient does not show intolerance.A syrup containing io mgm. per dr. is put up by

some manufacturers for children.Intravenous. In asthma and acute allergic con-

ditions some. drugs of this group have been givenintravenously (Lofstrom and Nurnberger, 1946;Rosenberg and Blumenthal, I949; Zolov, I949).Rosenburg and Blumenthal (i949) used a solutionof benadryl containing io mgm. per cc., anddiluted each cc. with 30 cc. of normal saline; 30mgm. were given slowly in this way. Side effectsinclude drowsiness, severe headache and rigors.There seems to be little advantage in this methodof administration.

Local application. In the itching dermatoses,ointments or creams containing 2 per cent. to5 per cent. of anthisan, benadryl or thephorinmay be effective (Wooldridge and Joseph, I948).Instillations of 0.5 per cent. to 2 per cent. solutionsinto the eye or the nose has been recommended inconjunctivitis or hay fever (Friedlaender, 1948;Brem and Zonis, I949; Zellen, 1949). Inhalationof 2 per cent. to 5 per cent. solutions in the formof an aerosol has been used in asthma.

Rectal. Gay (1949) gave dramamine rectallywith success in severe sea sickness.

It should be remembered that sudden with-drawal of antihistamine drugs after, regular treat-ment may lead to intensification of symptoms(' rebound phenomena') and the dose shouldtherefore be graduially reduced. The AmericanCouncil on Pharmacy and Chemistry (1949) haverecently issued a warning against indiscriminateuses of antihistamine substances. Side effectsmay be dangerous in car drivers or those handlingmachinery at work, and they suggest that theamounts being taken for ' persistent colds' mayexceed what has been established as normallysafe. They also wisely point out that it is not yetcertain that these drugs are harmless if takencontinually for long periods.

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THE LEGAL DUTY OF THE DOCTOR AS REGARDSSKILL AND CARE

By A BARRISTER

Let us suppose that A goes to B and asks B togive him medical advice and attention. B is nota doctor and tells him so, but A says that he hasevery confidence in B's common sense and thatis enough for him. If B then proceeds to treat Aand does his best but, owing to his lack of thenecessary skill and knowledge, A suffers someinjury from the treatment, A will not have anyremedy at law against B. He committed himselfto B at his own risk and (to quote a legal phrase)B did not warrant his skill. In short, the beginningof a doctor's liability to his patient lies in the factthat the doctor warrants his skill and holds himselfout as having the necessary skill and knowledgereasonably required for the discharge of theduties of his profession.What kind of a liability is this? Is it a liability

in contract or in tort? It is not necessary for meto deal with this distinction at any length. If amotorist carelessly knocks down a pedestrian andinjures him, he is liable in damages, although hehas no contract with the pedestrian and so com-rnitted no breach of contract by his careless driving.He is liable in tort. On the other hand, if I order

(say) potatoes of a certain quality and the trades-man accepts the order and then sends potatoes ofan inferior quality, I have an action against himfor breach of contract and I could not sue himunless I had a contract with him. In many in-stances a patient, whose doctor has failed to useproper care and has thereby caused some detri-ment to him, can sue the doctor in contract aswell as tort. In some instances he cannot sue incontract but only in tort, e.g. suppose the care-lessness occurs in the treatment of a patient whois brought into a hospital in an unconscious con--dition and occurs whilst he is still unsonscious, theidea of a contract between the patient and thedoctor would hardly seem appropriate to the cir-sumstances. But I shall not for present purpbsestrouble about this distinction in the cause of action,as lawyers call it. The damages recoverable wouldprobably be the same, whether the patient sued incontract or in tort or in both. I shall speak of thedoctor's duty and treat the word ' duty ' as cover-ing the whole of the doctor's responsibility in law,whatever be the legal conception from which it isderived, and I shall speak of a breach of that duty

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