Rapid Responses to:
|
|
Rapid Responses: Rapid Responses published:
-
![[Read Rapid Response]](/icons/misc/sectionDOWN.gif)
Scientific Silliness for Good Cause
- Ned Hoke (15 January 2001)
-
Ginkgo biloba and tinnitus
- Fabio Firenzuoli, Luigi Gori, Anna Crupi, Gioacchino Calapai (16 January 2001)
-
Successful pharmacological tinnitus treatment
- Andreas F P Temmel (16 January 2001)
-
Dose
- Cordey Jean-Pierre (19 January 2001)
-
Re: Successful pharmacological tinnitus treatment
- Christian Frankenfeld (29 January 2001)
-
In the absence of proven remedies, ginkgo still has a place in the treatment of tinnitus
- Tony Jefferies (2 February 2001)
-
Ginkgo for tinnitus
- Simone Breitkopf (4 February 2001)
-
validated scales?
- L Gallo (10 April 2001)
|
|
|||
|
Ned Hoke, private practice Western US
Send response to journal:
|
Fighting over-the-counter patent medicine commercial claims with such studies distracts comprehension of how genuinely functional herbology can usefully be utilized. It amounts to trite bad press, bad science and social irresponsibility. While it might be useful to know that this one herb, as applied, did not prove any magic bullet benefit such presentation obscures any real truth about the actual way clinical herbology, inclusive with ginkgo, offers benefit to the tinnitus sufferer. The claim of this response is these people tested in a predictably wrong direction and in so doing weakened potentially positive public knowledge of how to use plant medicines. |
|||
|
|
|||
|
Fabio Firenzuoli, Director Department of Phytotherapy, S.Giuseppe Hospital, Empoli, I, Luigi Gori, Anna Crupi, Gioacchino Calapai
Send response to journal:
|
Dear Editor: S. Dreaw and E. Davies conclude that 150 mg Ginkgo biloba daily for 12 weeks is no more effective than placebo in treating tinnitus (1), but probably enrolling patients simply affected by tinnitus, lasting not less than one year and mean age 52.9 years, they did not differentiate anyway patients and the type of tinnitus; while it has been demonstrated by statistical analysis on 259 patients affected by tinnitus of less than 1 year duration, that three parameters have prognostic significance: chronicity, periodicity and uni- or bilateral nature of symptoms (2). Regarding length of the treatment with Ginkgo biloba it should last much more to have an adequate clinical response irrespective of the specific individual clinical state of the patient (3). Besides the therapeutic action of Ginkgo biloba is played through inibition of edema and better capillary circulation and prevention ischemia (4), so it is easy to understand that an inveterate tinnitus can be very hardly be a responder to Ginkgo biloba treatment, while as shown by animal model (5), in recent onset tinnitus it may be a working treatment. Bibliography 1. Drew S; Ewart D.: Effectiveness of Ginkgo biloba in treating tinnitus: double blind, placebo controlled trail. BMJ 2001;322:1-6. 2. Meyer B.: A multicenter study of tinnitus. Epidemiology and therapy. Ann Otolaryngol Chir Cervicofac 1986;103(3):185-8 . 3. Meyer B.:Multicenter randomized double-blind drug vs. placebo study of the treatment of tinnitus with Ginkgo biloba extract. Presse Med 1986 Sep 25;15(31):1562-4 . 4.Calapai G; Crupi A; Firenzuoli F; et al.: Neuroprotective effects of Ginkgo biloba extract in brain ischemia are mediated by inhibition of nitric oxide synthesis. Life Sciences 2000, 67, 22, 2673-2683. 5. Jastreboff PJ; Zhou S; Jastreboff MM; et al.: Attenuation of salicylate -induced tinnitus by Ginkgo biloba extract in rats. Audiol Neurootol 1997 Jul-Aug;2(4):197-212 |
|||
|
|
|||
|
Andreas F P Temmel, Senior Registrar Dept. of ENT, University of Vienna, Austria
Send response to journal:
|
Dear Editor, the authors state that no pharmacological treatment for tinnitus is available at the moment. We would like to bring in mind a study by Denk-DM et al. who performed a placebo-controlled blind study using a single infusion of caroverine, a quinoxaline-derivative, successfully in the treatment of inner ear tinnitus [1]. They investigated a total of 60 randomised patients with cochlear-synaptic tinnitus. In the caroverine group, 63.3% responded to therapy immediately after the infusion. In the placebo group, none of the patients significant response according to the defined success criteria (reduction in both subjective rating and psychoacoustic measurement). The study was based (1) on the assumption that in the mammalian cochlea neurotransmission between inner hair cells and afferent auditory neurons glutamate or another related excitatory amino acid are the most important and (2) on the microiontophoretical experiments in guinea-pigs which have shown that caroverine acted as a potent competitive alpha-amino-3-hydroxy- 5-methyl-4-isoxazone-proprionic acid (AMPA) receptor antagonist and, in higher dosages, a non-competitive N-methyl-d-aspartate (NMDA) antagonist [2]. It is also known that neurotoxicity induced by excessive glutamate release seems to play a crucial role in some pathological conditions of the cochlea, such as ischaemia or noise trauma [3]. Thus, glutamate antagonists may be a new therapeutic strategy for different inner ear diseases, and have been demonstrated to work in cochlear synaptic tinnitus as above quoted. References: 1. Denk, D.M., et al., Caroverine in tinnitus treatment. A placebo- controlled blind study [see comments]. Acta Otolaryngol, 1997. 117(6): p. 825-30. 2. Ehrenberger, K. and D. Felix, Caroverine depresses the activity of cochlear glutamate receptors in guinea pigs: in vivo model for drug- induced neuroprotection? Neuropharmacology, 1992. 31(12): p. 1259-63. 3. Oestreicher, E., et al., New approaches for inner ear therapy with glutamate antagonists. Acta Otolaryngol, 1999. 119(2): p. 174-8. |
|||
|
|
|||
|
Cordey Jean-Pierre
Send response to journal:
|
Interesting article, yet the dosage of 50mg is not high enough too have any effect. 80-120mg/d in portion of max.40mg |
|||
|
|
|||
|
Christian Frankenfeld, university student / freelance journalist University of Paderborn
Send response to journal:
|
Dr. Temmel reminds us of trials with the glutamate antagonist caroverine performed at his clinic in 1997 (1). In the single-blinded study presented by Denk et al., 63.3% of the patients reported an improvement of their tinnitus after a single infusion with the drug. However, Dr. Temmel fails to mention that other authors were so far unable to verify this success rate. In an open study published by Domeisen et al. in 1998 (2), no successfull treatment of tinnitus patients with caroverine could be observed. Furthermore, the Domeisen and colleagues criticize the study design of Denk et al., highlighting the circumstance that single-blinded studies are unable to give propper evidence for the effectivness of a tested drug. This criticism was rected by Denk and colleauges in a comment on Domeisen's study though (3). Keeping this controversy in mind, it seems important to wait for the results of the double-blinded, randomized, multicenter study on the effectivness and tolerability of caroverine for tinnitus patients performed by S. Pluempe and colleagues in the University Clinic of Halle as well as in other treatment centers (4) before making any final judgement. Christian Frankenfeld References: 1. Denk DM, Heinzl H, Franz P, Ehrenberger K. Caroverine in tinnitus treatment. A placebo-controlled blind study. Acta Otolaryngol. 1997 Nov;117(6):825-30. 2. Domeisen H, Hotz MA, Hausler R. Caroverine in tinnitus treatment. Acta Otolaryngol. 1998 Jul;118(4):606-7. 3. Denk DM, Heinzl H, Franz P, Ehrenberger K. Caroverine in tinnitus treatment again: a reply to Domeisen et al. Acta Otolarnygol. 1998 Jul;118(4): 608. 4. Pluempe S, et al. A double-blinded, randomized, multicenter study on the effectivness and tolerability of caroverine for tinnitus patients. (Personal correspondance). Compare: http://www.medizin.uni-halle.de:81/hno/forschung/projekte.htm [German] Competing interest: Author's tinnitus was unsuccesfully treated with caroverine in Germany, December 1999. |
|||
|
|
|||
|
Tony Jefferies, former director British Tinnitus Association
Send response to journal:
|
3 points: Firstly, my compliments to Lichtwer Pharma. This company held a genuine belief that ginkgo had a direct pharmacological benefit in the treatment of tinnitus and had the courage to invest a lot of money in their conviction. Unfortunately, the results of this solidly constructed trial were not as they, and indeed all of us, had hoped. Secondly, it is interesting, though not directly relevant to the result, that the positive placebo effect over the entire trial (placebo pill and Ginkgo pill alike) was so unusually low - only 10% when 30% is typical in trials of this nature. The authors suggest that this may have been to the lack of personal contact with the participants. I suspect it was also due to negative publicity circulating among tinnitus sufferers around the time of the trial. The unsound suggestion, that 'ginkgo can have dangerous, possibly fatal side effects' was conceivably a matter of mild concern to some of the volunteers. Nevertheless, the important fact is that this confounding variable effected both groups equally so that there was no *relative* difference between the results for experimental group (gingko pill; 34 improvements), and the results for the control group (placebo pill; 35 improvements). Thirdly, I think that the final paragraph by the authors is of paramount importance. In the absence of proven remedies for tinnitus, the psychological benefits to be gained by belief in a therapy or treatment are highly beneficial to patient, permitting stress relief and thereby facilitating habituation. An interesting statistical consideration: Of people who believe strongly in a therapy or treatment, no matter how obscure or unlikely that treatment may be in a true scientific reality - in the small self- selecting sample of people who actually believe in a scientifically inert treatment - faith healing or whatever - around 80% of those devout participants will perceive a benefit from the cause that they believe in. And in the case of tinnitus, perception is reality. The purveyors of rival tinnitus treatments may benefit from this undeserved own goal by a courageous company, Lichtwer Pharma, but the fact remains:- Until a proven treatment emerges, Ginkgo remains a valid tool in the treatment of tinnitus. Tony Jefferies |
|||
|
|
|||
|
Simone Breitkopf, physician Karlsruhe/Germany
Send response to journal:
|
Dear Editor, Tinnitus is the perceived sensation of sound in the absence of any external acoustic stimulation. Tinnitus, like pain, is a subjective symptom not a disease and can have many different aetiologies. A thorough diagnostic process is necessary to try to identify the underlying condition and to choose an optimal therapeutic strategy. Many forms of treatment have been tried, but the effectiveness of pharmacological treatment still appears to be a controversial issue. This was emphasised by the recent publication of a double-blind, placebo-controlled trial with Ginkgo biloba extract LI 1370, in which the authors conclude that the extract was not effective in the treatment of tinnitus in the population under study. In contrast to a number of well- documented studies which have shown convincingly that Ginkgo biloba conforming to the standards of the German Commission E Monograph is effective in the treatment of tinnitus when defined objectively e.g. by audiometric measurements and tinnitus masking (see: Ernst & Stevinson (1999), Pawel et al. (1997), Holstein (2000) and Morgenstern & Biermann(1997)), this study employed questionnaires to collect data which provided a subjective assessment of tinnitus in patients recruited by post and contacted by telephone. No medical examinations were carried out and no reliable system of controlling patients' compliance was established. Furthermore, no information about adherence to GCP requirements was given. Without any specific methods (e.g. audiometry) for the proper assessment of the symptom in question or the differential diagnosis of the underlying disease, any conclusions about the value of the subjective data presented by Drew & Davies in assessing the efficacy of treatment with Ginkgo biloba must be viewed with caution. In conclusion, it appears that an effective treatment of tinnitus can only be attempted within the framework of thorough medical examinations and detailed knowledge of the underlying causes. Most clinical trials to date indicate that Ginkgo biloba is a useful tool which can support the clinician's ultimate aim of providing both objective and subjective relief for tinnitus patients. Literature: Ernst E. & Stevinson C. (1999) Ginkgo biloba for Tinnitus: a review. Clin. Otolaryngol. 24:164-167 Holstein N. (2000) Ginkgo-Spezialextrakt EGb 761 in der Tinnitus-Therapie. Fortschritte der Medizin 118: 157-164 Pawel J. Jastreboff (1997) Attenuation of Salicylate-Induced Tinnitus by Ginkgo biloba Extract in Rats. Audiol Neurootol 2: 197-212 Morgenstern C. & Biermann E. (1997) Ginkgo-Spezialextrakt EGb 761 in der Behandlung des Tinnitus aurium. Fortschritte der Medizin 115: 7-11 |
|||
|
|
|||
|
L Gallo
Send response to journal:
|
In the paragraph 'outcome measures' Drew and Davies speak of "previously validated self assessment scales" and cite the paper of Axelsson et al. (J. Audiol. Med., 1993,2, 141-150). I just read this paper and there is no word of validation. So here is my question: Can you tell me where I can find information about the validation of the outcome scales (or other validated tinnitus assessment scales)? Thanks in advance L. Gallo |
|||