Rapid Responses to:
|
|
Rapid Responses: Rapid Responses published:
-
![[Read Rapid Response]](/icons/misc/sectionDOWN.gif)
Mood Stabilisers? Other Anticonvulsants&Atypical Antipsychotics ought to be included.
- Abdul Karim Al-Sheikhli,MRCPsych , DPM. (27 August 2002)
-
Re: Mood Stabilisers? Other Anticonvulsants&Atypical Antipsychotics ought to be included.
- John R Geddes, OX3 7JX (27 August 2002)
-
Pharmaceutical Industry Involvement in BALANCE Trial
- Daniel V Riordan (9 September 2002)
|
|
|||
|
Abdul Karim Al-Sheikhli,MRCPsych , DPM., Loc.Consultant Medical Centre,2Manor Court Avenue,Nuneaton CV11 5HX,UK.
Send response to journal:
|
Dear Editor, It was interesting to read Geddes etal letter to the Editor `1`,and to hear that the team are currently conducting a large randomised trial in UK comparing valporate monotherapy..etc,But i would like to raise my observations on this trial,&Dinan Editorial `2`. 1.There was complete ignorance in that study to other mood stabilsers,like the 2nd line,3rd line,4th line anticonvulsants ,like Carbamazepine,Gabapentin,Lamotrigine,& the growing evidence of Atypical Antipsychotics as mood stabilsers`3`. 2.Although Dinan Editorial stress on hypothyrodism and increase in body weight as the main side effects,recent study mentioned that polyuria- polydipsia,&tremor as the main side effects with lithium therapy,`4`. 3.Although lithium can not be used in lactating women,& in pregnant women,but for e.g valporate are implicated in polycystic ovary disorder. So I think ,the study ought to include, 1.other anticonvalsants,like Carbamazepine,gabapentin,lamotrigine,etc. 2.Atypical antipsychotics,like olanzapine,risperidone..etc. still after 50 years from original Cade paper ,we seems still far from the understanding of the mode of action and long term side effects of lithium?. Ref, 1.Geddes J,Goodwin G,Rendell J,Hainsworth,etal,New trial should clarify Lithium use in bipolar disorder,BMJ,2002,325:441(24 August) 2.Dinan TG.Lithium in bipolar mood disorder,BMJ 2002;324:989-990(27April) 3.Ernst CL,Goldberg JF,The reproductive safety profiles of mood stabilisers,atypical antipsychotics &broad spectrum psychotropics,J.Clin.Psychiatry,2002,63,Suppl 4,42-55. 4.Henry C,Lithium side effects and predictors of hypothyrodism in patients,sex differences,J Psychiatry Neurosci 2002,Mar,27(2):104-107 |
|||
|
|
|||
|
John R Geddes, Principal Investigator University of Oxford, Warneford Hospital, Oxford, OX3 7JX
Send response to journal:
|
We thank Dr Al-Sheikhli for his interest in BALANCE. We agree that there are other promising new treatments for bipolar disorder that require further study in large randomised trials. We have conducted systematic reviews of most of the available compounds and these will shortly be available in the Cochrane Library.
It is essential, however, for a trial to focus on a single, clear important clinical question. As lithium and valproate are currently the most widely used mood stabilizers, it seems appropriate to start with them. But Dr Al-Sheikhli has raised an important issue – with new drugs both becoming available and increasingly used in clinical practice, the window of opportunity to complete any trial is probably quite narrow. Further trials will help us to identify the appropriate place of drugs such as olanzapine and lamotrigine in the long-term treatment of bipolar disorder. In the meantime, to help BALANCE recruit as quickly as possible, we would strongly encourage clinicians to become investigators in BALANCE. We would like to thank those clinicians who have contacted us following the publication of our letter. |
|||
|
|
|||
|
Daniel V Riordan, Consultant Psychiatrist New Craigs Hospital, Leachkin Road, Inverness, IV3 8NP
Send response to journal:
|
I have little doubt that the large randomised trial comparing Valproate and Lithium in the prophylaxis of Bipolar Affective Disorder (BALANCE)1 will be rigorously designed to the highest standards. The fact that the study is being funded by the independent Stanley Foundation is to be welcomed. It seems a pity that the involvement of Sanofi-Synthelabo is considered necessary. I appreciate that the organisers of such research face a dilemma in how to fund a large number of participants taking expensive medication over a two-year period. A medical profession that is absolutely independent of the pharmaceutical industry is probably unrealistic, if not undesirable. Nevertheless, claiming such independence, when it patently does not exist, can only be damaging. How can a piece of research be "conducted entirely independently of the pharmaceutical industry" if the trial drugs are being "generously donated" by the very pharmaceutical company which would seem to have the most to gain commercially from the trial being carried out? Do the investigators really believe that the company is acting out of generosity? What is not made clear in the communication from Geddes et al1, is that BALANCE is using, not the standard (and off patent) sodium valproate, but the more expensive, (more lucrative for Sanofi-Synthelabo), valproate semisodium2. However, the advantage of the later over the former, in the prophylaxis of Bipolar Affective Disorder, is anything but proven. Why not include a sodium valproate group in the trial? (The additional drug costs would be relatively modest). From a clinical and scientific perspective, (but perhaps not from a commercial one), comparing sodium valproate with valproate semisodium would be just as valid a question as the comparison between valproate semisodium and Lithium is. If it were demonstrated that valproate semisodium had no advantage over sodium valproate, the potential savings to the NHS would be considerable. An association has been demonstrated between authors' conclusions and any competing interests they may have3. Perhaps we should also be wary of the potential influence which competing interests could exert on what research does, or does not, get done in the first place. I am not in any way questioning the validity of the BALANCE trial, merely the claim to independence. As an increasingly more cynical public are questioning the relationship between the pharmaceutical industry and the medical profession, independent research must not only be done, it must be seen to be done. Daniel Vincent Riordan, Consultant Psychiatrist, New Craigs Hospital, Leachkin Road, Inverness. IV3 8NP REFERENCES 1 Geddes J, Goodwin G, Rendell J, Hainsworth J, Van der Gucht E, Young H. New trial should clarify lithium use in bipolar disorder. BMJ 2002;325:441 (24 August) 2 BALANCE (Bipolar Affective Disorder; Lithium Anticonvulsant Evaluation) Trial Protocol. Warenford Hospital, Oxford. July 2002. www.psychiatry.ox.ac.uk/balance 3 Kjaergard L, Als-Nielsen B. Association between competing interests and authors' conclusions: epidemiological study of randomised clinical trials published in the BMJ BMJ 2002; 325: 249 (3 Aug) |
|||